The year 2020 was an extraordinary year. In the face of the sudden outbreak of COVID-19, the Center for Drug Evaluation of the National Medical Products Administration (hereinafter referred to as the Drug Evaluation Center), under the strong leadership of the National Medical Products Administration (hereinafter referred to as the National Medical Products Administration), earnestly studied and implemented the important speeches and instructions of General Secretary Xi Jinping. Responding to the call, we mobilized all our resources, adhered to the principle of putting people and life first, and established an emergency review and approval work mechanism for 'early intervention, continuous tracking, proactive service, and collaborative review' to accelerate the research and development and market launch of COVID-19 vaccines and treatment drugs. We fully leveraged the role of technical review in supporting epidemic prevention and control; actively served the overall situation of the drug regulatory system, closely focused on implementing the reform of the review and approval system by the Party Central Committee and the State Council, implementing the Drug Administration Law, Vaccine Administration Law, and Drug Registration Management Measures, promoting the modernization of the review system and review capabilities, coordinating the advancement of epidemic prevention and control and scientific review in accordance with the law, continuously improving review quality and efficiency, and accelerating the pace of new drug research and development and market launch. This provided effective drug guarantees for epidemic prevention and control and meeting clinical urgent needs, and strongly promoted the high-quality development of the pharmaceutical industry, ensuring the safety, effectiveness, and accessibility of medications for the public. The drug review cause has achieved new development, reached new heights, and opened up new situations.
　　1. Review and approval status of drug registration applications
　　(1) Overall completion status
　　1. Completion status of review and approval throughout the year
　　In 2020, according to the Drug Registration Management Measures (Order No. 27 of the State Administration for Market Regulation), the Announcement of the National Medical Products Administration on Implementing the Drug Registration Management Measures (Announcement No. 46 of 2020, hereinafter referred to as Announcement No. 46), and relevant supporting documents of the Drug Registration Management Measures, the Drug Evaluation Center completed a total of 11,582 registration application reviews and approvals for traditional Chinese medicine (including ethnic medicine), chemical drugs, and biological products (including 4 combination products, counted by acceptance number), an increase of 32.67% compared to 2019 (unless otherwise specified, counted by the number of registration applications). Among them, 8,606 registration applications requiring technical review were completed (including 5,674 applications requiring technical review and administrative approval by the Drug Evaluation Center), an increase of 26.24% compared to 2019; 2,972 registration applications were completed through direct administrative approval (no technical review required). By the end of 2020, the number of registration applications under review and awaiting review had decreased from nearly 22,000 at the peak in September 2015 to 4,882 (excluding registration applications that completed technical review but were awaiting supplementary materials from the applicant due to defects in the application materials).
　　Among the 8,606 drug registration applications requiring technical review completed, there were 6,778 chemical drug registration applications, an increase of 25.22% compared to 2019; 418 traditional Chinese medicine registration applications, an increase of 39.33% compared to 2019; and 1,410 biological product registration applications, an increase of 27.72% compared to 2019. Chemical drug registration applications accounted for approximately 78.76% of the total technical review completion volume. For details on the completion status of registration application reviews for traditional Chinese medicine, biological products, and chemical drugs from 2016 to 2020, see Figure 1.

　　Among the 8,606 registration applications requiring technical review completed by the Drug Evaluation Center, 1,561 new drug clinical trial (IND) application reviews were completed, an increase of 55.94% compared to 2019; 289 new drug marketing application (NDA) reviews were completed; 1,700 generic drug marketing application (ANDA) reviews were completed; 1,136 consistency evaluation applications (submitted via supplementary application) were completed, an increase of 103.22% compared to 2019; and 3,250 supplementary application technical reviews were completed, an increase of 24.19% compared to 2019. For details on the completion status of various types of registration application reviews from 2016 to 2020, see Figure 2.

　　3. Review approval status
　　In 2020, the Drug Evaluation Center approved 1,435 IND applications, an increase of 54.97% compared to 2019; approved 208 NDAs, an increase of 26.83% compared to 2019; approved 918 ANDAs; and approved 577 consistency evaluation applications, an increase of 121.92% compared to 2019.
　　The Drug Evaluation Center approved 20 varieties of innovative drug NDAs and 72 varieties of overseas-produced original drug NDAs (including newly added indications). For specific varieties, see Attachments 1 and 2.
　　4. Timely completion status of registration application tasks
　　In 2020, the Drug Evaluation Center continuously optimized the review process, strictly managed review timelines, strengthened project supervision, and accelerated review speed. The overall timely completion rate of review tasks and key sequence review tasks achieved significant improvement. The overall timely completion rate of registration application tasks for the year was 94.48%, with a 100% timely completion rate for registration applications for urgently needed overseas marketed new drugs, a 99.87% timely completion rate for registration applications accepted under implied permission, and 100% of direct administrative approval registration applications completed within the statutory 20 working days, with an average approval time of 11.8 working days. For the timely completion status of various types of registration application tasks, see Table 1.

　　The overall timely completion rate for NDA applications in 2020 has significantly improved. For example, the timely completion rate for NDAs exceeded 80% in December 2020, rising to 87.5%; the timely completion rate for ANDAs exceeded 90% in December 2020, reaching 93.85%; and the timely completion rate for registration applications included in the priority review process reached over 90% in the monthly timely completion rates from October to December 2020, achieving a historic breakthrough.
　　(2) Completion status of traditional Chinese medicine registration application reviews
　　1. Overall status
　　In 2020, the Drug Evaluation Center completed reviews of 418 traditional Chinese medicine registration applications. Among them, 37 IND applications were completed, 8 NDAs were completed, and 3 ANDAs were completed. For the completion status of various types of traditional Chinese medicine registration applications in 2020, see Figure 3.

　　2. Review approval status
　　The Drug Evaluation Center approved 28 traditional Chinese medicine IND applications, and approved 4 traditional Chinese medicine NDAs (Lianhua Qingke Tablets, Jingu Zhitong Gel, Sangzhi Total Alkaloid Tablets, and Sangzhi Total Alkaloid). For specific completion status of various types of traditional Chinese medicine registration applications in 2020, see Table 2. For the approval status of traditional Chinese medicine IND applications and NDAs from 2016 to 2020, see Figure 4.

 

　　The Drug Evaluation Center approved 28 traditional Chinese medicine IND applications, covering 10 indication areas. Among them, there were 7 for respiratory indications, 4 for orthopedic indications, and 4 for digestive indications, accounting for 53.57%. For the distribution of indications for traditional Chinese medicine IND applications approved in 2020, see Figure 5.

　　(3) Completion status of chemical drug registration application reviews
　　1. Overall status
　　In 2020, the Drug Evaluation Center completed reviews of 6,778 chemical drug registration applications. Among them, 1,086 chemical drug clinical applications (IND applications and verification clinical) were completed, an increase of 45.58% compared to 2019; 163 chemical drug NDAs were completed; 1,697 chemical drug ANDAs were completed; 1,136 consistency evaluation applications were completed, an increase of 103.22% compared to 2019; and 2,248 chemical drug supplementary applications were completed, an increase of 23.72% compared to 2019. For the completion status of various types of chemical drug registration applications in 2020, see Figure 6.

　　2. Review approval status
　　The Drug Review Center completed the review of chemical drug registration applications, approving 907 IND applications, an increase of 51.42% compared to 2019; 115 NDA approvals, an increase of 30.68% compared to 2019; and 918 ANDA approvals, an increase of 15.33% compared to 2019. For detailed information on the review of various chemical drug registration applications completed in 2020, see Table 3.

　　The Drug Review Center completed the review of 960 chemical drug IND applications, approving 907 IND applications. Among them, there were 694 Class 1 innovative chemical drug IND applications (298 varieties), an increase of 40.77% compared to 2019, with the number of varieties increasing by 57.67% compared to 2019. For the review and approval of chemical drug IND applications and Class 1 innovative chemical drug IND applications from 2016 to 2020, see Figure 7.

　　Among the 694 Class 1 innovative chemical drugs approved by the Drug Review Center, there were many anti-tumor drugs, anti-infective drugs, drugs for circulatory system diseases, endocrine system drugs, digestive system disease drugs, and rheumatic disease and immune drugs, accounting for 80.69% of the total number of approved innovative drug clinical trials. For the distribution of indications for the Class 1 innovative chemical drug IND applications approved in 2020, see Figure 8.

　　The Drug Review Center completed the review of a total of 163 chemical drug NDAs. Among them, 115 chemical drug NDAs were approved, and 14 varieties of Class 1 innovative chemical drug NDAs were approved. For the review and approval of chemical drug NDAs from 2016 to 2020, see Figure 9.

 

　　The Drug Review Center completed the review of a total of 1136 consistency evaluation applications, approving 577 of them. Among them, 456 approvals for oral solid dosage forms and 121 approvals for injection consistency evaluations were granted, with specific varieties detailed in Appendix 3. For the review and approval of consistency evaluation applications from 2018 to 2020, see Figure 10.

　　(4) Completion of the review of biological product registration applications.
　　1. Overall status
　　In 2020, the Drug Review Center completed the review of a total of 1410 biological product registration applications. Among them, 27 applications for preventive biological product INDs, 537 applications for therapeutic biological product INDs, an increase of 58.88% compared to 2019; 9 preventive biological product NDAs, 108 therapeutic biological product NDAs, and 1 in vitro diagnostic reagent NDA were completed. For the review completion status of various biological product registration applications in 2020, see Figure 11.

　　2. Review approval status
　　The Drug Review Center approved 500 biological product IND applications, an increase of 60.26% compared to 2019. Among them, there were 19 preventive IND applications; 481 therapeutic IND applications, an increase of 63.61% compared to 2019. The Drug Review Center approved 89 biological product NDAs, an increase of 20.27% compared to 2019. Among them, there were 7 preventive NDAs; 81 therapeutic NDAs (77 formulations), an increase of 19.12% compared to 2019; and 1 in vitro diagnostic NDA. For the specific completion status of various biological product registration applications in 2020, see Table 4, and for the approval of biological product IND applications and NDAs from 2016 to 2020, see Figure 12.

 

　　The Drug Review Center approved 500 biological product IND applications, and the distribution of indications for the biological product IND applications approved in 2020 is shown in Figure 13. The Drug Review Center approved 89 biological product NDAs, and the distribution of indications for the biological product NDAs approved in 2020 is shown in Figure 14.

　　(5) Completion status of administrative approval registration applications.
　　1. Overall status
　　In 2020, the Drug Review Center completed a total of 8646 administrative approvals for registration applications of traditional Chinese medicine, chemical drugs, and biological products, an increase of 44.51% compared to 2019. Among them, 5674 registration applications (clinical trial applications, consistency evaluation applications, supplementary applications, re-registration of drugs produced abroad, and re-examinations) were completed, an increase of 39.24% compared to 2019; 2972 registration applications (supplementary applications and temporary import applications that do not require technical review) were directly administratively approved, an increase of 55.77% compared to 2019. For the completion status of administrative approvals for registration applications of traditional Chinese medicine, chemical drugs, and biological products in 2020, see Table 5. For the completion status of administrative approval registration applications from 2018 to 2020, see Figure 15.

　　2. Completion status of registration applications requiring review and approval.
　　Among the 5674 registration applications requiring review and approval completed by the Drug Review Center, there were 1686 clinical trial applications (including verification clinical trials), an increase of 50.00% compared to 2019; 623 consistency evaluation applications, an increase of 80.58% compared to 2019; 2860 supplementary applications, an increase of 34.46% compared to 2019; 478 re-registrations of drugs produced abroad, and 27 re-examinations.
　　3. Completion status of registration applications for direct administrative approval.
　　Among the 2972 registration applications completed by the Drug Review Center for direct administrative approval, classified by application type, there were 2537 supplementary applications and 435 temporary import applications. Classified by drug type, there were 153 traditional Chinese medicine applications, 2411 chemical drug applications, and 408 biological product applications.
　　(6) Main reasons for the disapproval of registration applications and existing issues.
　　In 2020, a total of 367 registration applications for traditional Chinese medicine, chemical drugs, and biological products were suggested not to be approved due to the inability to prove the safety, efficacy, or quality controllability of the drugs based on the submitted materials, as well as failure to submit supplementary materials on time. By systematically sorting out the reasons for the disapproval of the above registration applications, the main issues in the drug registration application process from the perspective of different registration categories such as new drugs and generic drugs include:
　　1. New drug applications.
　　The issues in IND applications and research mainly include: lack of communication before formal submission; insufficient basis for development topics, with serious defects in drug properties; submitted materials insufficient to support the conduct of clinical trials or ensure the safety of clinical trial subjects. Specific manifestations include: lack of communication leading to serious omissions in research information discovered after submission, making it impossible to complete supplementary research within the time limit; existing research results indicating weak efficacy, high toxicity, and unreasonable benefit-risk ratios; clinical development positioning violating basic principles of clinical diagnosis, treatment, and medication; existing pharmaceutical and preclinical research not meeting clinical trial requirements; serious defects in the overall design of clinical trial protocols, with insufficient risk control measures; insufficient non-clinical research data for combination therapy; insufficient data for individual vaccines in combination vaccines and/or inconsistent immunization schedules.
　　The issues in NDA research and submission mainly include: defects in research quality control and management, leading to existing research results failing to prove the safety, efficacy, and quality controllability of the drugs; violations of compliance requirements. Specific manifestations include: major defects in the design of key clinical studies, making it impossible to obtain objective and strong evidence of efficacy and safety; serious defects in pharmaceutical research, making it impossible to prove the quality controllability of the product; inconsistencies in research samples at various development stages; authenticity issues found in clinical trial data during registration verification.
　　2. Generic drug applications.
　　The main issues in the application for consistency evaluation and marketing of generic drugs include: unreasonable research topics for generic drug development; application materials failing to prove the quality consistency of the generic drug with the reference formulation (the drug being replicated). Specific manifestations include: the reference formulation of the generic drug has been withdrawn from the market, and there are newer products with better safety that meet clinical needs; sample re-examination does not comply with regulations or there are serious defects in the analytical methods; human bioequivalence test results indicate non-equivalence; sample stability study results, selection of starting materials for active pharmaceutical ingredients, etc., do not meet the technical requirements for the marketing of generic drugs; the generic drug did not use legally sourced active pharmaceutical ingredients as required.
　　3. Supplementary Application
　　The main issues in the research and application of supplementary applications include: application materials failing to sufficiently explain the scientific and rational basis for the changes, which is inadequate to support the change matters; existing research results cannot guarantee the safety, efficacy, and quality controllability of the product after the change. Specific manifestations include: changes causing significant alterations to the basis of the medicinal substance; the application for modification of the drug instructions does not meet the technical requirements for writing instructions; the literature used to support the changes is biased, or clinical safety and efficacy data are insufficient.
　　4. Others
　　The main issues in the registration applications for other drugs during research and application include: a lack of similarity comparison data in the development of biosimilars, defects in the selection of reference drugs in pharmaceutical comparison studies; insufficient preclinical research results for biosimilars to support their clinical trials; research data on natural drugs not meeting the basic technical requirements for international multi-center clinical trials or the evaluation of natural drugs in our country.
　　(7) Situation of Accelerated Drug Marketing Registration Procedures
　　Innovation is the driving force for the high-quality development of drugs. The "Drug Registration Management Measures" combines the actual development of China's pharmaceutical industry and clinical needs, referencing international experience, and establishes four accelerated marketing procedures: special approval, breakthrough therapy drugs, conditional approval, and priority review and approval. The "Announcement of the National Medical Products Administration on the Release of the <Review Work Procedures for Breakthrough Therapy Drugs (Trial)> and Other Three Documents" (No. 82 of 2020) clarifies the scope of application, applicable conditions, work procedures, and policy support for the accelerated channel, which can significantly improve the operability in the execution of related procedures, encourage drug development and innovation, and, under the global context of fighting the pandemic, implement special approvals for drugs needed for epidemic prevention and control in accordance with laws and regulations, playing an important role in accelerating the marketing of drugs urgently needed in clinical settings, with outstanding clinical value, and for public health needs. For details on the drugs approved for marketing in 2020 that are included in the accelerated marketing procedures, see Attachment 4.
　　1. Situation of Special Approval Drugs
　　In the event of a threat from a public health emergency and after the occurrence of such an event, the National Medical Products Administration may decide to implement special approval for drugs needed for the prevention and treatment of the public health emergency in accordance with the law. For drugs included in the special approval procedure, the National Medical Products Administration organizes the accelerated and synchronized acceptance, review, verification, and inspection of drug registration according to the principles of unified command, early intervention, rapid efficiency, and scientific approval, and limits their use within a certain period and scope based on the specific needs of disease prevention and control.
　　In 2020, as the COVID-19 pandemic spread globally, the safety of people's lives was severely threatened. The Drug Review Center responded promptly, scientifically and efficiently advancing special review work, and included 59 applications for the registration of traditional Chinese medicine, chemical drugs, and biological products into the special approval process, completing technical reviews. One application was recommended for conditional approval for marketing, which was for an inactivated vaccine for the novel coronavirus (Vero cells); 53 clinical trial applications were recommended for approval, of which 5 had entered phase III clinical trials, and clinical trial applications for Granules for Clearing Dampness and Detoxification and Granules for Clearing Lung and Detoxification were approved; 5 supplementary applications for increasing indications for Lianhua Qingwen Capsules/Granules, Jinhua Qinggan Granules, and Xuebijing Injection were approved, accelerating the marketing process of COVID-19 vaccines and treatment drugs, initially meeting the needs for COVID-19 epidemic prevention and control.
　　2. Situation of Breakthrough Therapy Drugs
　　Breakthrough therapy drugs refer to innovative drugs or modified new drugs used for the prevention and treatment of severe life-threatening diseases or diseases that severely affect the quality of life, for which there are no effective prevention and treatment methods or sufficient evidence indicating significant clinical advantages compared to existing treatment methods. Applicants can apply for the breakthrough therapy drug procedure during phase I and II clinical trials. According to the "Review Work Procedures for Breakthrough Therapy Drugs (Trial)", drugs included in the "breakthrough therapy" review channel will be prioritized for related communication and guidance to promote the drug development process; during the application for marketing, the drug can apply for priority review and approval procedures, further shortening the review time; during the marketing application phase, the Drug Review Center will continuously accept its application materials and prioritize verification, inspection, etc., which can greatly reduce the time from drug development to marketing. In 2020, the Drug Review Center received 147 applications for breakthrough therapy drugs. After comprehensive evaluation and public announcement, 24 applications (21 varieties) for breakthrough therapy drugs have been included in the breakthrough therapy drug procedure, see Attachment 5 for details.
　　3. Situation of Conditionally Approved Drugs
　　Conditional approval for marketing aims to shorten the research and development time of clinical trials for drugs, allowing them to be applied as soon as possible for patients with critical diseases or urgent public health needs who cannot wait any longer. The efficacy evaluation indicators for drugs are clinical endpoints. Drugs that meet the conditions for conditional approval for marketing can use alternative endpoints, intermediate clinical endpoints, or early clinical trial data to reflect the efficacy of the drug. When these data indicate that the benefits of the drug outweigh the risks, an application for conditional approval for marketing can be made.
　　For patients with diseases that would lead to death within months or even shorter if not treated promptly, drugs approved for conditional marketing allow these patients who cannot wait any longer to extend their lives and improve their quality of life, eliminating the threat to people's safety posed by major public health emergencies. In 2020, among the new drug marketing applications reviewed and approved by the Drug Review Center, a total of 15 registration applications were approved for marketing after conditional approval, covering indications such as diseases caused by novel coronavirus infection, non-small cell lung cancer, and ovarian cancer.
　　4. Situation of Priority Review Drugs
　　(1) Inclusion of Priority Review Varieties
　　The adjustment of the priority review and approval procedures in the "Drug Registration Management Measures" is an optimization based on years of practical experience. First, the scope of application focuses more on drugs with significant clinical value, urgent clinical needs, and clinical advantages, aiming to include more drugs with significant clinical value, urgently needed shortage drugs, drugs for the prevention and treatment of major infectious diseases, rare diseases, and pediatric drugs, as well as drugs included in the breakthrough therapy program and those eligible for conditional approval into the priority review procedures; second, the acceleration of review timelines, where the review timeline for drug marketing license applications is generally 200 working days, compared to a complete application path, the review timeline for priority review and approval procedures is shortened to 130 working days, with the review timeline for urgently needed rare disease drugs already marketed abroad being 70 working days. The Drug Review Center strives to complete the review on time by optimizing the allocation of review resources while achieving high standards in technical reviews, promoting the rapid approval of varieties included in the priority review and approval procedures.
　　According to the "Drug Registration Management Measures", Announcement No. 46, and the "National Medical Products Administration's Opinions on Encouraging Drug Innovation to Implement Priority Review and Approval" (Document No. 126 [2017]), in 2020, the Drug Review Center included 219 registration applications (counting 127 varieties by generic name) into the priority review and approval process. Among them, 144 registration applications were included in the priority review and approval process according to the scope specified in Document No. 126, and 75 were included according to the scope specified in the "Drug Registration Management Measures", including 42 pediatric drugs and drugs for rare diseases. For details on the various registration applications included in the priority review and approval process from 2016 to 2020, see Table 6 and Table 7.
  

21. Table 6.png

22. Table 7.png

 

 

　　Among the registration applications included in the previous priority review scope, the proportion of simultaneous declarations reached 44% (64/144), and the proportion of new drugs with significant clinical value was 20%. The proportion of varieties re-declared after improvement according to the standards consistent with the quality and efficacy of the original research drugs decreased from 7.9% to 4.2%.
　　Among the registration applications included in the priority review scope according to the "Drug Registration Management Measures", the proportion of drugs approved with conditions was 36% (27/75), and the proportion of innovative drugs and pediatric drugs was 28% (21/75). Priority review resources have been tilted towards innovative and urgently needed drugs with significant clinical value.
　　(2) Completion of priority review varieties
　　In 2020, 217 registration applications (counting 121 varieties by generic name) were recommended for approval for marketing through the priority review process (including new indications for already marketed drugs), with the number of approvals increasing by 51.7% compared to 2019. For example, domestically developed Class I innovative drugs such as Amivantamab tablets, Zepzelca capsules, and Obinutuzumab tablets, treatments for the rare disease Fabry disease, Agalsidase alpha injection concentrated solution, traditional Chinese medicine new drug Mulberry Branch Total Alkaloid Tablets for controlling type 2 diabetes in conjunction with diet and exercise, and the adult relapsing multiple sclerosis treatment drug Sinomide tablets, etc. For details on the varieties approved through priority review from 2016 to 2020, see Table 8.

 

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　　(8) On-site verification related situation for drug registration
　　1. Overall status
　　The Drug Review Center actively implements the "Drug Registration Management Measures", transforming the concept of drug registration verification, and adjusting the initiation of on-site verification work mode from being based on review needs to being based on risk initiation, conducting technical review and on-site verification work in parallel; for registration applications accepted from July 1, 2020, a decision on whether to initiate the corresponding on-site verification task will be made within 40 working days after acceptance. To facilitate applicants in timely obtaining information related to the initiation of on-site verification, the Drug Review Center has improved the applicant window section of its website, opened a channel for submitting production processes and quality standards for on-site verification, and enabled the function of receiving electronic notification letters for on-site verification.
　　2. Specific situation of on-site verification
　　In 2020, the Drug Review Center initiated 1235 on-site verification tasks based on variety factors and compliance factors of the R&D production entities. Among them, there were 792 pharmaceutical on-site verification tasks, 439 clinical trial data verification tasks, and 4 pharmacology and toxicology research verification tasks.
　　The Drug Review Center received 818 verification reports. Among them, there were 449 pharmaceutical on-site verification reports, 363 clinical trial verification reports, and 6 pharmacology and toxicology research verification reports.
　　(9) Communication and exchange situation
　　1. Overall status
　　In 2020, while implementing epidemic prevention and control requirements, the Drug Review Center tried to meet the needs of applicants and fully ensured smooth communication and exchange. In promoting the R&D of COVID-19 vaccines and treatment drugs for COVID-19, communication and exchange between applicants and the Drug Review Center's review team were organized over 5600 times for 79 COVID-19 vaccines, traditional Chinese medicine, and neutralizing antibodies (27 items) and other COVID-19 treatment drugs. A separate ledger was established for key varieties such as COVID-19 vaccines and neutralizing antibodies, with dynamic follow-up; in maintaining communication with applicants, the Drug Review Center issued the "Management Measures for Communication and Exchange in Drug R&D and Technical Review" and the "Notice on Contact Methods for Business Consultation Services", optimized telephone consultation services, and designated personnel to answer applicants' consultation calls daily. Eight contact email addresses were set up based on different types of consultation issues to promptly answer and handle applicants' questions, continuously improving the quality and efficiency of communication and exchange.
　　The Drug Review Center received 3229 applications for communication and exchange meetings, an increase of 22.64% compared to 2019, and processed 2451 applications for communication and exchange meetings, an increase of 31.00% compared to 2019. On the online platform, 20285 general technical problem consultations were received, an increase of 22.41% compared to 2019; over ten thousand telephone consultations were received, and thousands of email consultations were received, while also providing on-site consultation services to the public. For details on the communication and exchange applications and general technical problem consultations received from 2016 to 2020, see Figure 16.

 

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　　2. Completion of communication and exchange meeting applications
　　Among the 3229 communication and exchange meeting applications received by the Drug Review Center, those that met the conditions for holding meetings were promptly contacted by the applicants to discuss meeting details; for those that did not require a meeting, written replies were provided to the applicants as soon as possible. In 2020, a total of 2451 communication and exchange meeting applications were processed. The proportion of Class II meetings held at critical stages of drug R&D was 76.42%, with pre-IND applications accounting for 37.49%. For details on the various communication and exchange meeting applications and processing in 2020, see Table 9.

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　　The forms of communication and exchange meetings included telephone meetings, video meetings, and face-to-face meetings, with a total of 268 communication and exchange meetings held, and over two thousand written replies provided. For details on the holding of various communication and exchange meetings from 2018 to 2020, see Table 10.

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　　3. Response situation for general technical questions
　　The Drug Review Center received a total of 20285 consultations on general technical questions through the online consultation platform. According to content classification, the questions mainly focused on acceptance (4038), raw and auxiliary materials (3952), etc.; according to drug classification, the questions mainly focused on chemical drugs (11338), among which chemical drug acceptance (2396) and chemical drug consistency evaluation (1258). For details on the response situation for general technical questions, see Table 11.

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　　II. Situation of drug registration application acceptance
　　(1) Overall situation
　　In 2020, according to Announcement No. 46, the "Notice from the National Medical Products Administration on the Release of Registration Classification and Application Requirements for Biological Products" (No. 43, 2020), the "Notice from the National Medical Products Administration on the Release of Registration Classification and Application Requirements for Chemical Drugs" (No. 44, 2020), and the "Notice from the National Medical Products Administration on the Release of the <Registration Classification and Application Requirements for Traditional Chinese Medicine>" (No. 68, 2020), the Drug Review Center accepted a total of 10,245 registration applications for traditional Chinese medicine, chemical drugs, and biological products (including 6 combination products), an increase of 26.76% compared to 2019. Among them, 7,147 registration applications required technical review (including 5,695 applications requiring technical review and administrative approval from the Drug Review Center), an increase of 15.29% compared to 2019; 3,092 registration applications were directly approved administratively, an increase of 64.64% compared to 2019.
　　Among the 10,239 accepted drug registration applications, the number of accepted chemical drug registration applications was 7,901, an increase of 22.02% compared to 2019, accounting for 77.17% of all registration applications accepted in 2020. The acceptance status of various drug registration applications from 2016 to 2020 is detailed in Figure 17.
 

28. Figure 17.png

 

　　The direct administrative approval work of the Drug Review Center began in 2017, so there were no direct administrative approval registration applications in 2016; all accepted registration applications required technical review.
　　In 2020, among the 7,147 registration applications requiring technical review, there were 5,402 chemical drug registration applications, an increase of 9.42% compared to 2019, accounting for 75.58% of all registration applications requiring technical review; there were 315 traditional Chinese medicine registration applications, an increase of 22.57% compared to 2019; and there were 1,430 biological product registration applications, an increase of 42.29% compared to 2019. The acceptance status of various registration applications requiring technical review from 2016 to 2020 is detailed in Figure 18.

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　　(2) Acceptance Status of Class 1 Innovative Drugs
　　In 2020, the Drug Review Center accepted a total of 1,062 Class 1 innovative drug registration applications (597 varieties), an increase of 51.71% compared to 2019. Among them, 1,008 IND applications (559 varieties) were accepted, an increase of 49.78% compared to 2019; 54 NDA applications (38 varieties) were accepted, an increase of 100.00% compared to 2019. By drug category, the acceptance numbers for Class 1 innovative drugs were 14 for traditional Chinese medicine, 752 for chemical drugs, and 296 for biological products. By production site, there were 843 domestic production drug applications and 219 overseas production drug applications. See Tables 12 and 13 for details.

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　　(3) Acceptance Status of Various Registration Applications
　　1. Acceptance Status of Traditional Chinese Medicine Registration Applications
　　In 2020, the Drug Review Center accepted 471 traditional Chinese medicine registration applications. Among them, 22 traditional Chinese medicine IND applications, 6 traditional Chinese medicine NDA applications, and 1 traditional Chinese medicine ANDA application were accepted. The acceptance status of various traditional Chinese medicine registration applications in 2020 is detailed in Figure 19.

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　　14 Class 1 innovative traditional Chinese medicine registration applications were accepted, including 9 IND applications (9 varieties) and 5 NDA applications (5 varieties).
　　2. Acceptance Status of Chemical Drug Registration Applications
　　In 2020, the Drug Review Center accepted 7,901 chemical drug registration applications. Among them, 946 chemical drug IND applications were accepted, an increase of 36.31% compared to 2019; 191 NDA applications were accepted, an increase of 46.92% compared to 2019; 1,125 ANDA applications were accepted, an increase of 7.45% compared to 2019; and 914 consistency evaluation applications were accepted, a decrease of 11.95% compared to 2019. The acceptance status of various chemical drug registration applications in 2020 is detailed in Figure 20. The acceptance status of various chemical drug registration applications from 2016 to 2020 is detailed in Figure 21.

33. Figure 20.png

 

 

34. Figure 21.png

 

 

　　The Drug Review Center accepted 752 Class 1 innovative chemical drug registration applications (360 varieties), an increase of 31.24% compared to 2019. Among them, 721 IND applications (339 varieties) were accepted, an increase of 30.62% compared to 2019; and 31 NDA applications (21 varieties) were accepted, an increase of 47.62% compared to 2019.
　　The Drug Review Center accepted 160 Class 5.1 chemical drug registration applications, an increase of 1.91% compared to 2019. Among them, 53 clinical trial applications (verification clinical) and 107 NDA applications were accepted.
　　Among the 360 varieties of Class 1 innovative chemical drug registration applications, there were 258 varieties for domestic production and 102 varieties for overseas production. The acceptance status of Class 1 innovative chemical drug registration applications from 2016 to 2020 is detailed in Figure 22.

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　　3. Acceptance Status of Biological Product Registration Applications
　　In 2020, the Drug Review Center accepted 1,867 biological product registration applications. Among them, 580 biological product IND applications were accepted (25 preventive IND applications and 555 therapeutic IND applications), an increase of 87.10% compared to 2019; 126 NDA applications were accepted (7 preventive NDA applications, 117 therapeutic NDA applications, and 2 in vitro diagnostic reagent applications), an increase of 1.62% compared to 2019. The acceptance status of various biological product registration applications in 2020 is detailed in Figure 23. The acceptance status of biological product IND and NDA applications from 2016 to 2020 is detailed in Figure 24.

 

 

 

36. Figure 23.png

37. Figure 24.png

 

 

 

　　The Drug Review Center accepted 296 Class 1 innovative biological product registration applications (223 varieties), an increase of 133.07% compared to 2019. Among them, 5 preventive biological product applications and 291 therapeutic biological product applications were accepted; 278 biological product IND applications (211 varieties) were accepted, an increase of 129.75% compared to 2019; and 18 biological product NDA applications (12 varieties) were accepted, an increase of 200.00%. For specific details, see Table 14.

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　　4. Acceptance Status of Administrative Approval Registration Applications
　　(1) Overall Situation
　　In 2020, the Drug Review Center accepted 8,787 registration applications for traditional Chinese medicine, chemical drugs, and biological products requiring administrative approval from the center, an increase of 29.51% compared to 2019. Among them, 5,695 registration applications requiring review and approval (clinical trial applications, consistency evaluation applications, supplementary applications, re-registration and review of overseas produced drugs) were accepted, an increase of 16.06% compared to 2019; and 3,092 registration applications for direct administrative approval (supplementary applications and temporary import applications that do not require technical review) were accepted, an increase of 64.64% compared to 2019. The specific acceptance status of administrative approval registration applications in 2020 is detailed in Table 15. The acceptance status of administrative approval registration applications from 2016 to 2020 is detailed in Figure 25.

39. Table 15.png

40. Figure 25.png
 

　　(2) Acceptance of registration applications requiring review and approval
　　The Drug Review Center accepted 5,695 registration applications requiring review and approval, including 1,618 clinical trial applications (including verification clinical), 914 consistency evaluation applications, 2,827 supplementary applications, 328 re-registration applications for overseas produced drugs, and 8 re-examinations.
　　(3) Acceptance of registration applications for direct administrative approval
　　The Drug Review Center accepted 3,092 registration applications for direct administrative approval, categorized by application type: 2,644 supplementary applications and 448 temporary import applications. By drug type, there were 156 traditional Chinese medicine, 2,499 chemical drugs, and 437 biological products.
　　III. Key therapeutic area varieties
　　COVID-19 vaccines and COVID-19 treatment drugs:
　　1. Inactivated vaccine for the novel coronavirus (Vero cells), the first COVID-19 vaccine conditionally approved in China and the world's first inactivated COVID-19 vaccine. It is suitable for the prevention of diseases caused by infection with the novel coronavirus (SARS-CoV-2) in individuals aged 18 and older.
　　2. The "three drugs" varieties recommended in the "Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia (Trial)" are Lianhua Qingwen granules/capsules, Jinhua Qinggan granules, and Xuebijing injection. Lianhua Qingwen granules/capsules and Jinhua Qinggan granules have new indications for the treatment of fever, cough, and fatigue caused by mild and ordinary types of COVID-19 in routine treatment. Xuebijing injection has new indications for the systemic inflammatory response syndrome or/and multiple organ failure in severe and critical COVID-19 patients. Its approval and marketing fully demonstrate the role of traditional Chinese medicine in epidemic prevention and control.
　　3. Injection of Sevelamer Sodium, a selective inhibitor of neutrophil elastase, is suitable for improving acute lung injury/acute respiratory distress syndrome (ALI/ARDS) associated with systemic inflammatory response syndrome. It is the only drug globally used for ALI/ARDS, and its approval fills the gap in the treatment of ALI/ARDS in China, providing medication options for critically ill respiratory patients.
　　Antitumor drugs:
　　4. Amivantamab tablets, the first third-generation targeted epidermal growth factor receptor (EGFR) small molecule tyrosine kinase inhibitor (TKI) with independent intellectual property rights in China, is suitable for treating locally advanced or metastatic non-small cell lung cancer with confirmed EGFR T790M mutation positivity that has progressed after previous EGFR-TKI treatment. This product has outstanding efficacy and good control of brain metastases, and its approval will significantly improve the accessibility of treatment drugs for this disease.
　　5. Surufatinib capsules, a multi-target, anti-angiogenesis oral small molecule tyrosine kinase inhibitor, is the first innovative drug in China for the treatment of unresectable locally advanced or metastatic, progressive non-functional, well-differentiated (G1, G2) neuroendocrine tumors of non-pancreatic origin. This product has outstanding efficacy, significantly reducing the risk of disease progression and death in such patients, and its approval fills the gap in the treatment of this disease.
　　6. Injection of Brentuximab Vedotin, the world's first CD30-targeted antibody-drug conjugate (ADC), is also the first ADC drug for malignant lymphoma patients in China, suitable for treating relapsed or refractory systemic anaplastic large cell lymphoma and classical Hodgkin lymphoma. Its approval provides an effective treatment method to improve the long-term survival of such patients in China.
　　7. Injection of Blinatumomab, the world's first bispecific antibody (CD3 and CD19 targets) drug, is also the first bispecific antibody drug for tumor indications in China, suitable for treating adult relapsed or refractory precursor B-cell acute lymphoblastic leukemia. For patients with relapsed or refractory acute lymphoblastic leukemia who failed chemotherapy, this product can significantly extend survival compared to standard chemotherapy, and its approval provides better treatment options for such patients in China.
　　8. Lenvatinib mesylate capsules, a multi-target, oral tyrosine kinase inhibitor, is the first small molecule drug in China for the treatment of progressive, locally advanced, or metastatic radioactive iodine-refractory differentiated thyroid cancer. This product has outstanding efficacy, and its approval provides an effective treatment option for such patients in China, filling the gap in this treatment area.
　　Antiinfective drugs:
　　9. Velpatasvir capsules, a non-structural protein 5A (NS5A) inhibitor, is an innovative broad-spectrum, direct-acting antiviral drug for hepatitis C virus with independent intellectual property rights in China, suitable for use in combination with sofosbuvir to treat treatment-naive or interferon-treated adults with chronic hepatitis C virus infection of genotypes 1, 2, 3, and 6, with or without compensated liver cirrhosis. Its approval provides a new treatment option for chronic hepatitis C patients in China.
　　10. Emtricitabine and Tenofovir tablets, with added indications for reducing the risk of HIV-1 acquisition in adults and adolescents (weighing at least 35 kg) through high-risk behaviors, is the first drug in China for pre-exposure prophylaxis of HIV. HIV infection is a major public health issue, and its approval is of great significance for controlling HIV transmission.
　　Cardiovascular drugs:
　　11. Lanadelumab injection, a fully humanized monoclonal antibody (IgG1/K-light chain), is the first drug in China for the prevention of hereditary angioedema (HAE) attacks in patients aged 12 and older. HAE is a recurrent disease, and nearly half of patients may experience upper respiratory mucosal edema leading to life-threatening asphyxiation. Its approval provides a safe and effective treatment method for preventing attacks in HAE patients in China.
　　12. Diflunisal soft capsules, a transthyretin (TTR) stabilizer, are suitable for treating transthyretin amyloidosis cardiomyopathy to reduce cardiovascular mortality and cardiovascular-related hospitalizations. This disease is a fatal condition and is classified as a rare disease. This product is the first drug in China targeting the etiology of this disease, and its approval provides new treatment options for such patients in China.
　　Respiratory system drugs:
　　13. Brompheniramine nasal spray is a cholinergic receptor antagonist and is the first nasal anticholinergic innovative drug with independent intellectual property rights in China for allergic rhinitis. It is suitable for improving symptoms such as runny nose, nasal congestion, nasal itching, and sneezing caused by allergic rhinitis. The approval of this product provides new treatment options for patients in China with this condition.
　　14. Nintedanib esylate soft capsules are small molecule tyrosine kinase inhibitors with antifibrotic effects, increasing indications for the treatment of systemic sclerosis-related interstitial lung disease (SSc-ILD) and chronic fibrotic interstitial lung disease (PF-ILD) with a progressive phenotype. Currently, effective treatment options for SSc-ILD and PF-ILD are limited, and there is an urgent clinical need for medication. The approval of this product to add indications can fill the gap in this treatment area and provide drug options for patients in China.
　　Neurological drugs:
　　15. Deutetrabenazine tablets are vesicular monoamine transporter 2 (VMAT2) inhibitors and are the first drug in China for the treatment of chorea associated with the rare disease Huntington's disease and tardive dyskinesia. It is included in the list of urgently needed new drugs from abroad, and the approval of this product meets the urgent clinical needs of patients in China.
　　16. Chlorphenesin acetate soft capsules are transthyretin (TTR) stabilizers and are the first drug in China for treating adult patients with stage I symptoms of transthyretin amyloidosis polyneuropathy, delaying peripheral nerve function damage. It is included in the list of urgently needed new drugs from abroad, and its approval changes the situation of having no treatment for this disease.
　　Analgesics and anesthetic drugs:
　　17. Remimazolam injection is a GABAA receptor agonist and is an innovative drug used for sedation during gastrointestinal endoscopy. This product has a similar pharmacological mechanism to the commonly used anesthetic sedative drug propofol but has advantages such as rapid onset, less injection pain, mild respiratory depression, and quick recovery. Its approval provides a new option for medication used in gastrointestinal endoscopy procedures in China.
　　Dermatological and ophthalmological drugs:
　　18. Cenegermin eye drops are the first recombinant human nerve growth factor (rhNGF) drug in China for the treatment of neurotrophic keratitis (NK). It is included in the list of urgently needed new drugs from abroad. NK is a rare degenerative corneal disease that can cause blindness, and surgical treatment for moderate to severe NK is invasive, costly, and cannot provide a permanent cure. The approval of this product provides effective treatment for patients in China with this condition and is expected to become the first choice for moderate to severe NK patients.
　　19. Dupilumab injection is a recombinant human immunoglobulin-G4 monoclonal antibody suitable for treating adults with moderate to severe atopic dermatitis that is poorly controlled by topical prescription drugs or for whom topical prescription drugs are not recommended. It is included in the list of urgently needed new drugs from abroad. Compared to existing treatment methods, this product has significant clinical advantages, and its approval provides treatment options for patients with such difficult-to-treat severe diseases.
　　Gastrointestinal drugs:
　　20. Vedolizumab injection is a humanized monoclonal antibody that acts on human lymphocyte integrin α4β7, suitable for treating moderate to severe active ulcerative colitis and Crohn's disease in patients who have inadequate response, loss of response, or intolerance to traditional treatments or tumor necrosis factor-α (TNF-α) inhibitors. It is included in the list of urgently needed new drugs from abroad. There is an urgent clinical treatment need for such diseases, especially for patients who have failed TNF-α antagonist treatment. The approval of this product provides new treatment options for clinical use.
　　Surgical drugs:
　　21. Dantrolene sodium injection is suitable for the prevention and treatment of malignant hyperthermia (MH) and is currently the only drug that can change the outcome of this disease when administered in a short time. MH has critical clinical outcomes and a high mortality rate. Its approval changes the current situation in China where there are no safe and effective treatment methods for MH, meeting urgent clinical needs.
　　22. Tacrolimus granules are suitable for preventing graft rejection in children after liver or kidney transplantation and for treating graft rejection that cannot be controlled by other immunosuppressive drugs after liver or kidney transplantation in children. This product is approved for pediatric use and can greatly address the unmet clinical needs of pediatric liver and kidney transplant patients in China.
　　Rare disease drugs:
　　23. Laronidase injection is the first enzyme replacement therapy drug in China for the rare disease mucopolysaccharidosis type I (MPS I, α-L-iduronidase deficiency). It is included in the list of urgently needed new drugs from abroad. MPS I is a severe life-threatening genetic rare disease with no effective treatment methods available in China and has been included in the first batch of rare disease catalogs in the country. The approval of this product fills the medication gap for patients with this condition in China.
　　24. Idursulfase injection is the first enzyme replacement therapy drug in China for the rare disease mucopolysaccharidosis type II (MPS II, Hunter syndrome). MPS II is a severe life-threatening genetic rare disease with no effective treatment methods available in China and has been included in the first batch of rare disease catalogs in the country. The approval of this product fills the medication gap for patients with this condition in China.
　　In vitro diagnostic reagents:
　　25. Recombinant tuberculosis fusion protein (EC) is suitable for diagnosing tuberculosis infection in infants aged 6 months and older, children, and adults under 65 years old, and can be used to assist in the clinical diagnosis of tuberculosis. It is the world's first in vitro diagnostic product used to differentiate between BCG vaccination and tuberculosis infection. Its approval provides new means for clinical differential diagnosis.
　　Preventive biological products (vaccines):
　　26. Nasal spray freeze-dried influenza live attenuated vaccine: This is the first vaccine in China administered via nasal spray, suitable for individuals aged 3 (36 months) to 17 years for the prevention of influenza caused by vaccine-related strains of the influenza virus. After vaccination, it can stimulate the body to produce immunity against the influenza virus.
　　New traditional Chinese medicine:
　　27. Mulberry branch total alkaloid tablets, whose main component is the total alkaloids extracted from mulberry branches, is the first new traditional Chinese medicine approved for the market in the past 10 years for diabetes treatment, suitable for dietary control and exercise in the treatment of type 2 diabetes. This product can effectively reduce the glycosylated hemoglobin levels in type 2 diabetes subjects, providing new treatment options for type 2 diabetes patients.
　　28. Muscle and joint pain relief gel, a new traditional Chinese medicine compound made from 12 medicinal ingredients including vinegar, Corydalis, and Chuanxiong, is suitable for improving symptoms of knee osteoarthritis with kidney deficiency and blood stasis. It has the effects of "activating blood circulation, regulating qi, dispelling wind and dampness, and relieving pain." This product is an external gel formulation, with each component acting through transdermal absorption, avoiding gastrointestinal absorption and first-pass metabolism in the liver, providing new treatment options for patients with knee osteoarthritis.
　　29. Lianhua Qingke tablets, a new traditional Chinese medicine made from 15 medicinal ingredients including Ephedra and mulberry bark, are suitable for treating cough and phlegm caused by acute tracheobronchitis with phlegm-heat obstructing the lungs. It has the effects of "dispersing lung heat and resolving phlegm to stop cough." Its approval provides new treatment options for patients with acute tracheobronchitis.
　　IV. Make every effort to do a good job in emergency review work.
　　(1) Strengthen unified leadership and formulate work procedures.
　　In accordance with the deployment of the National Medical Products Administration (NMPA) Party Group regarding emergency review and approval work for epidemic prevention and control, the Drug Review Center acted promptly. First, it fully utilized collective decision-making, quickly established a special review leadership group for anti-novel coronavirus drugs, and selected 148 key personnel from 16 departments as members of the working group. It held 6 special review leadership group meetings and 18 thematic meetings to clarify work principles, optimize work processes, and timely research and resolve issues encountered during the emergency review process, ensuring smooth and orderly work progress. Second, it formulated work procedures, forming one plan, two procedures, and one specification, namely the "Special Review Work Plan for Anti-Novel Coronavirus Drugs by the Drug Review Center," "Procedures for the Review of Drug Project Applications for Novel Coronavirus (2019-nCoV)," "Procedures for Evaluation and Review by the Special Expert Group for Novel Coronavirus (2019-nCoV) Drugs," and "Management Norms for the Expert Meeting on Anti-Novel Coronavirus Drugs by the NMPA." Third, it strictly implemented the work requirements of "safety as the bottom line, efficacy with evidence, quality assurance, and extraordinary review," conducting reviews in accordance with laws and regulations, scientifically and normatively, without lowering standards, and accelerating approvals.
　　(2) Leverage expert roles to solve technical difficulties.
　　First, a special expert group was formed. According to the "Special Approval Procedures for Drugs by the National Medical Products Administration" (originally NMPA Order No. 21) and the decisions of the NMPA's COVID-19 response working group for drugs, the Drug Review Center selected several academicians and well-known experts to form a special expert group, which began work after approval from the NMPA. When encountering new technical difficulties, expert opinions and suggestions were solicited, followed by a vote among experts. Second, emphasis was placed on utilizing expert technical support. Specific technical issues were addressed through expert seminars and consultations, for example, regarding the difficulties and potential risks in the development of mRNA COVID-19 vaccines, the Drug Review Center organized experts to form technical guidance principles to guide related enterprises in their research and development.
　　(3) Real-time efficient communication to improve R&D progress.
　　First, following the work requirements of "early intervention, continuous follow-up, and proactive service," the review team was organized at the first opportunity to evaluate the scientificity and feasibility of the consulting varieties or registration application projects, and communicated with the applicants within 24 hours to ensure that applicants could quickly submit special approval registration applications. Second, international cooperation was strengthened. Actively participated in video conferences organized by the World Health Organization (WHO), the International Coalition of Medicines Regulatory Authorities (ICMRA), etc., to jointly discuss R&D review standards, understand information on COVID-19 vaccine development, and guide and promote R&D enterprises to conduct Phase III clinical trials abroad.
　　(4) Explore the linkage between research and review, adhering to scientific review.
　　First, explore the establishment of a linkage mechanism between R&D and review. By conducting R&D, submitting, and reviewing simultaneously, valuable time was gained for the development of COVID-19 vaccines, ensuring that the R&D of COVID-19 vaccines and other related products stays at the forefront globally. This working mechanism significantly shortened the review time. Second, establish a technical standard system. In response to the characteristics of the novel coronavirus, 28 technical documents such as technical guidance principles for the development of COVID-19 vaccines and treatment drugs were timely formulated to guide enterprises in high-standard R&D and conduct scientific reviews.
　　V. Encourage the inheritance and innovative development of traditional Chinese medicine.
　　Implement the important instructions of General Secretary Xi Jinping on traditional Chinese medicine, the "Opinions of the Central Committee of the Communist Party of China and the State Council on Promoting the Inheritance and Innovative Development of Traditional Chinese Medicine," and the requirements of the NMPA. The Drug Review Center actively encourages the innovation of traditional Chinese medicine from various aspects, including reforming the registration classification of traditional Chinese medicine and improving technical guidance principles. First, promote the inheritance and development of traditional Chinese medicine. Drafted and published by the NMPA, the "Registration Classification and Application Material Requirements for Traditional Chinese Medicine" expands the scope of ancient classic prescriptions and promotes the R&D of traditional Chinese medicine compound preparations based on ancient classic prescriptions, facilitating their transformation into new drugs. Second, establish and improve a quality control system that meets the characteristics of traditional Chinese medicine. Following the characteristics and R&D rules of traditional Chinese medicine, the unique theoretical system and practical characteristics of traditional Chinese medicine, and the general requirements for drug quality control were organically combined to study and construct quality control methods and strategies that meet the characteristics of traditional Chinese medicine preparations. Eight technical guidance principles were formulated, including the "Guiding Principles for the Research of Processing Methods for New Traditional Chinese Medicine Decoction Pieces (Trial)," "Technical Guidance Principles for the Research of Quality Standards for New Traditional Chinese Medicine (Trial)," "Technical Guidance Principles for the Research of Production Processes for Traditional Chinese Medicine Compound Preparations (Trial)," and "Technical Guidance Principles for the Research of Biological Effect Detection of Traditional Chinese Medicine (Trial)." Third, improve the review system that meets the characteristics of traditional Chinese medicine. New tools, methods, and standards were introduced for the efficacy evaluation of traditional Chinese medicine, and the requirements for application materials were refined. Technical guidance principles such as "Technical Guidance Principles for Clinical Research of New Traditional Chinese Medicine for Chronic Constipation" and "Technical Guidance Principles for Clinical Research of New Traditional Chinese Medicine for Diabetic Nephropathy" were formulated to explore the establishment of a review evidence system that combines traditional Chinese medicine theory, human experience, and clinical trials. Fourth, make every effort to do a good job in the special review of traditional Chinese medicine. Fully promote the spirit of fighting the epidemic, and formulated the "Special Approval Application Material Requirements for Traditional Chinese Medicine Registration for COVID-19 (Trial)" and "Technical Guidance Principles for Special Approval Applications for Traditional Chinese Medicine Registration for COVID-19 (Trial)," guiding the review of traditional Chinese medicine in emergency situations. As of December 31, 2020, the IND applications for Qingfei Paidu Granules and Huashi Baidu Granules in the "three-party" have been approved, and the indications for the treatment of COVID-19 have been added for the "three drugs" Lianhua Qingwen Granules/Capsules, Jinhua Qinggan Granules, and Xuebijing Injection. Fifth, conduct field research and discussions in Wuhan to continuously promote the research project on the safety evaluation of traditional Chinese medicine guided by clinical value. Sixth, carry out assistance work in Xinjiang and Tibet, conduct field research in Tibet, and hold online discussions with the Xinjiang Uygur Autonomous Region Drug Administration to support the development of ethnic medicines.
　　VI. Strengthen the revision and formulation of supporting documents for the "Drug Registration Management Measures."
　　The newly revised "Drug Registration Management Measures" is an important regulation to implement the spirit of the reform of the review and approval system by the Central Committee of the Communist Party of China and the State Council, as well as to implement the newly revised "Drug Administration Law." Considering the specific technical requirements in drug registration management, it is necessary to continuously adjust and improve in line with technological development. Therefore, specific technical requirements will be released in the form of supporting documents and technical guidance principles after the publication of the "Drug Registration Management Measures," which can better conform to the scientific laws of drug research and development, and ensure a smooth transition between the old and new "Drug Registration Management Measures" and the successful implementation of the new measures.
　　According to the deployment of the National Bureau, the Drug Review Center coordinates and increases the efforts in the formulation and revision of supporting documents, establishes research groups to conduct research on key and difficult issues, fully listens to the opinions of experts and the industry, and strives to reach a consensus. A total of 48 supporting documents have been involved in the formulation and revision work, with 30 documents drafted as the lead. Since the work began, the public consultation on supporting documents has been basically completed, and some documents have been published and implemented after approval by the National Bureau, effectively ensuring that various review tasks are continuous, organized, and orderly, and facilitating the smooth transition and implementation of the old and new registration-related regulations.
　　VII. Accelerate the construction of the review technical standards system.
　　In the process of drug review and development, the guiding principles serve a dual function of regulatory basis and technical requirements. The "Drug Registration Management Measures" clearly states that those engaged in drug research and drug registration activities must comply with relevant laws, regulations, rules, standards, and norms; professional technical institutions such as the Drug Review Center should formulate technical guidance principles and procedures based on scientific progress, actual industry development, and the needs of drug supervision and management, and publish them to the public.
　　The establishment and improvement of the drug technical guidance principles system is the best practice to implement the "four strictest" requirements and an important measure for the Drug Review Center to promote the modernization of the review system and review capabilities. The Drug Review Center plans the construction of the review standards system centered on guiding principles through a three-step approach of "setting standards, defining procedures, and planning," focusing on the needs of drug research and development and encouraging innovation, benchmarking against the technical standards of advanced international regulatory agencies, and increasing the formulation and public disclosure of guiding principles. In 2020, a total of 119 technical guidance principles were formulated and revised. According to the requirements of the "Notice on the Issuance of the Procedures for the Release of Drug Technical Guidance Principles" (Drug Supervision Comprehensive [2020] No. 9) issued by the National Medical Products Administration, as of December 31, 2020, the Drug Review Center has published 71 guiding principles approved by the National Medical Products Administration, as detailed in Attachment 6.
　　In response to the COVID-19 pandemic and to promote the quality and speed of the research and review of COVID-19 vaccines and treatment drugs, the Drug Review Center issued 7 guiding principles, including the "Technical Guidance Principles for the Research and Development of Vaccines for the Prevention of COVID-19 (Trial)." To enhance the quality research of traditional Chinese medicine and encourage the research and innovation of traditional Chinese medicine, 10 guiding principles were issued, including the "Technical Guidance Principles for Quality Control Research of Medicinal Materials for New Traditional Chinese Medicines (Trial)," the "Technical Guidance Principles for the Production Process Research of Traditional Chinese Medicine Compound Preparations (Trial)," and the "Technical Guidance Principles for Clinical Research of New Traditional Chinese Medicines for Chronic Constipation (Trial)." To encourage the research and development of pediatric drugs, 3 guiding principles were issued, including the "Technical Guidance Principles for Real-World Research Supporting Pediatric Drug Development and Review (Trial)." To support the research and development of anti-tumor drugs and further meet the applicants' needs for specific guiding principles for anti-tumor drugs, 22 guiding principles were issued, including the "Technical Guidance Principles for Clinical Trials of Anti-Tumor Drug Combination Therapy" and the "Guidance Principles for Clinical Trials of Trastuzumab Biosimilars for Injection." To improve the quality of generic drugs and promote the consistency evaluation of generic drugs, the review standards and criteria were standardized, and 9 guiding principles were issued, including the "Technical Requirements for Quality and Efficacy Consistency Evaluation of Chemical Drug Injectables" and the "Technical Requirements for Quality and Efficacy Consistency Evaluation of Chemical Drug Injectables (Special Injectables)." These guiding principles cover hot and difficult issues such as emergency review standards for COVID-19, pediatric medication, technical standards system for traditional Chinese medicine, research and development of anti-tumor drugs, and research and development of generic drugs, continuously improving the drug technical guidance principles system, effectively promoting drug research and innovation, optimizing unified review standards, significantly enhancing review quality and efficiency, and greatly reducing review discretion.
　　VIII. Continue to deepen the reform of the drug review and approval system.
　　(1) Accelerate the review of urgently needed new drugs that have been marketed abroad.
　　Deeply implement the spirit of the State Council's executive meeting and fulfill the requirements to accelerate the review of urgently needed new drugs that have been marketed abroad. Based on the identification of the first and second batches of 74 varieties, the National Medical Products Administration and the National Health Commission organized relevant experts to study and demonstrate, selecting urgently needed new drug varieties. The Drug Review Center published the list of the third batch of 7 varieties. For varieties that meet the conditions specified in the "Announcement on Related Matters Concerning the Review and Approval of Urgently Needed New Drugs from Abroad" (2018 No. 79) issued by the National Medical Products Administration and the National Health Commission, the National Medical Products Administration, in conjunction with the National Health Commission, has organized a thorough selection, basically solving the problem of slow market entry for urgently needed new drugs from abroad in China, further improving public access to medications.
　　In 2020, the Drug Review Center completed the technical review of 13 urgently needed drugs for the treatment of rare diseases, all within the specified time limits. The review of rare disease drugs was completed within 3 months, while other urgently needed drugs were reviewed within 6 months, significantly shortening the time gap for urgently needed new drugs from abroad to enter the Chinese market. As of December 31, 2020, among the three batches of 81 urgently needed new drugs that have been marketed abroad, 48 varieties from 38 companies have submitted registration applications, of which 39 varieties have been approved for marketing or completed review, with 100% of the reviews completed within the time limits, as detailed in Attachment 7.
　　(2) Accelerate the promotion of the consistency evaluation of generic drugs.
　　In 2020, the Drug Review Center took practical and effective measures to accelerate the promotion of the consistency evaluation of generic drugs.
　　First, based on the consistency evaluation of oral solid preparations, actively promote the consistency evaluation of injectables. On May 12, the National Medical Products Administration issued the "Announcement on the Consistency Evaluation of Quality and Efficacy of Generic Chemical Drug Injectables" (2020 No. 62), officially launching the consistency evaluation work for injectables. The Drug Review Center published the "Technical Requirements for Quality and Efficacy Consistency Evaluation of Generic Chemical Drug Injectables," the "Application Requirements for Quality and Efficacy Consistency Evaluation of Generic Chemical Drug Injectables," and the "Technical Requirements for Quality and Efficacy Consistency Evaluation of Chemical Drug Injectables (Special Injectables)." In response to the 620 injectable consistency evaluation applications pending review before the official launch, the Drug Review Center established a special review working group, implemented detailed classification processing measures, strictly enforced one-time supplements, clarified the random principle for injectable consistency evaluation registration inspections, and accelerated the review speed, completing the review of 620 varieties in less than 5 months, with consistency evaluation reviews entering a normalized state.
　　Second, continue to standardize the selection of reference preparations and strengthen services and guidance. The Drug Review Center issued the "Application Requirements for the Selection of Reference Preparations for Chemical Generic Drugs" (Drug Review Center Notice 2020 No. 32), further emphasizing the self-inspection phase for applicants and improving the efficiency of reference preparation selection work. By further standardizing internal review, expert committee review, and other processes, the reference preparation selection work was optimized in 2020. Since the consistency evaluation work began in August 2017, a total of 35 batches of reference preparation catalogs have been published, involving 3,963 specifications (1,703 varieties), including 975 specifications (405 varieties) for injectable reference preparations.
　　Third, strengthen information disclosure and training. In July 2020, an online technical seminar on the consistency evaluation of chemical generic injectable drugs was held to explain the technical requirements for injectable drug consistency evaluation, special injectable drug technical requirements, and reference formulation application document requirements.
　　Fourth, continue to promote the filing of bioequivalence tests. In 2020, the bioequivalence test filing platform for chemical drugs collected a total of 672 records, while the bioequivalence test filing platform for generic drug consistency evaluation collected 292 records.
　　(3) Fully implement risk management during clinical trials.
　　To implement the safety risk management work during clinical trials as stipulated in the Drug Administration Law and the Drug Registration Management Measures, the Drug Review Center, under the guidance of the National Medical Products Administration, issued three supporting documents: "Safety Information Assessment and Management Specifications for Drug Clinical Trials (Trial)"; "Safety Update Report Management Specifications during R&D (Trial)"; and "Drug Clinical Trial Registration and Information Disclosure Management Specifications (Trial)". To further strengthen the monitoring, identification, assessment, and risk control of safety information during clinical trials, the "Drug Clinical Trial Safety Information Assessment and Risk Management Work Procedure (Trial)" was developed, and the "Safety Risk Management System during Clinical Trials" was launched to conduct systematic risk assessments of safety information during clinical trials, such as Suspected Unexpected Serious Adverse Reactions (SUSAR) and Development Safety Update Reports (DSUR).
　　In 2020, the Drug Review Center received 164,403 SUSAR case reports from both domestic and international sources (involving 57,995 cases). Among them, 17,243 SUSAR case reports came from China (involving 4,647 cases); a total of 1,775 DSURs were received; and 2,610 clinical trial registrations were completed (including COVID-19 vaccines and treatments for COVID-19). For the safety risks identified in 18 drug clinical trials, further risk control measures were proposed, including general risk control (such as modifying clinical trial protocols, revising informed consent forms, updating investigator brochures, and supplementing risk control measures) and recommending that applicants voluntarily suspend clinical trials.
　　In response to the sudden and severe COVID-19 pandemic, the Drug Review Center explored the establishment of a mechanism and channel for applicants to report on the progress of clinical trials, standardized relevant work procedures and technical requirements, issued the "Guiding Principles for the Management of Drug Clinical Trials during the COVID-19 Pandemic (Trial)", and developed standardized documents for the management of clinical trial progress and safety monitoring of emergency approval products. Through daily and weekly dynamic risk communication, effective risk monitoring and control were implemented. From February 2, 2020, to December 31, 2020, dynamic safety monitoring was conducted for 39 clinical trials of 15 vaccines, 16 biological products, 6 chemical drugs, and 2 traditional Chinese medicines approved through special approval procedures, completing a total of 195 reports on the progress and safety monitoring of emergency-approved COVID-19 vaccines and treatments.
　　The Drug Review Center participated in the drafting of the "Good Pharmacovigilance Practice (GVP)" and wrote relevant content and requirements for pharmacovigilance during clinical trials. The translation and publication of the "Safety Information Management during Clinical Trials: CIOMS VI Working Group Report" were completed, and an academic exchange video conference on "Management of Clinical Trials and Application of Remote Intelligent Technology during the Pandemic" was held to explore the safety management of remote intelligent clinical trials, steadily improving the capacity for safety information assessment and risk management during clinical trials.
　　(4) Continue to strengthen the scientific foundation of review.
　　1. Construction of the review quality management system.
　　Play a safeguarding role in the continuous and effective operation of the drug review work through the review quality management system. On one hand, it addresses the risks and challenges brought by the implementation of new laws and regulations on review business work, and in conjunction with the requirements of the Drug Registration Management Measures and its supporting documents, timely organizes a comprehensive revision of system documents such as the "Quality Manual", strengthening the integration of drug review business and quality systems; on the other hand, it responds to the impact of the COVID-19 pandemic on review work by conducting special internal supervision inspections at the Drug Review Center, fully training the internal auditor team, promptly identifying existing risks, and organizing improvements; at the same time, it continues to conduct annual satisfaction surveys to collect opinions and suggestions from the National Medical Products Administration and applicants regarding the Drug Review Center's implementation of new registration requirements and risk prevention and control during the COVID-19 pandemic, providing ideas for improving review quality and efficiency, and leveraging the quality system to support various work.
　　2. Strengthen the construction of review informatization.
　　To ensure the standardization, normalization, and digitization of various review reform work processes, the Drug Review Center vigorously promotes informatization construction, based on the Drug Registration Management Measures and a process-oriented scientific management system, with the drug review business process as the foundation, and improves the drug technical review system based on actual work. A new platform for professional review inquiries before and after supplementary applications was added, optimizing the communication system, strengthening proactive communication with applicants during the review period, and promoting the development of review business work; a new objection handling review and registration inspection online channel was added, the priority review and approval system was adjusted, and the operability of the review process was strengthened to ensure the smooth implementation of review and approval work. An online appointment acceptance channel was opened to reduce personnel movement and gatherings, effectively ensuring the orderly handling of applicant acceptance business during the COVID-19 pandemic; a breakthrough therapy designation program was added to encourage innovation and expedite the market entry of urgently needed clinical products. Through informatization means, the management of drug review and approval business is supported, network information security is strengthened, and the quality and efficiency of drug review and approval work are continuously improved. Currently, 10,674 enterprises have registered for real-name applications in the applicant window of the Drug Review Center's website, achieving full coverage of online business handling for drug, active pharmaceutical ingredient, excipient, and packaging material registration applicants.
　　(5) Actively promote the construction of a process-oriented scientific management system.
　　To implement the spirit of the Fourth and Fifth Plenary Sessions of the 19th CPC Central Committee, strengthen the construction of governance systems and governance capabilities, and take the construction of a process-oriented scientific management system as a starting point to continuously promote the modernization of the drug review system and review capabilities. According to the preliminary work plan, the Drug Review Center has fully launched the pilot construction of a scientific management system for eight sub-topics: task acceptance, task allocation, professional review, comprehensive review, communication, expert consultation, written supplementary applications, and inspection verification, and issued eight documents including the "Notice on Issues Related to the Operation of the Drug Professional Review Process-Oriented Scientific Management System". A plan for the revision of scientific management system regulations (including 28 regulations) was formulated, and as of December 31, 2020, 14 regulations had been completed. Emphasis was placed on the informatization of pilot construction results, incorporating various measures into the review information system, enhancing the rigid constraints of measure implementation, and improving scientific supervision and intelligent review capabilities.
　　A quarterly reporting mechanism was established to regularly organize reports on the operation of pilot projects. A management ledger for reform measures was established, incorporating 58 reform measures that need supervision, and monthly integrated dynamic management was conducted on the implementation of responsibilities, progress, new issues, and solutions for each reform measure. Pilot promotion symposiums and sub-topic conclusion symposiums were held to summarize and analyze the progress, effectiveness, and issues of each sub-topic pilot. A long-term operational mechanism to promote pilot construction was established, and the scientific review, efficient review, and clean review were promoted in a normalized and integrated manner.
　　(6) Continue to carry out ICH work.
　　Effectively promote the alignment of China's drug review and approval system with international standards and participate in the international coordination of ICH guidelines. First, actively participate in the coordination of ICH topics. Since the former National Medical Products Administration joined ICH in 2017, 69 experts have been sent to 36 ICH working groups, and 437 ICH working group conference calls were participated in 2020. Second, further promote the implementation of ICH Level 3 guidelines. The National Medical Products Administration has issued 3 announcements on the applicability and recommended applicability of ICH guidelines. Third, organize training on ICH guidelines. The Drug Review Center conducted 15 online training sessions on ICH guidelines, focusing on the technical points, implementation status, and potential issues during implementation of 29 ICH guidelines. The training participants mainly included relevant staff from the National Medical Products Administration, its directly affiliated units, provincial drug regulatory authorities, and provincial drug inspection institutions, with a total of 2,723 people watching the live training and 4,244 people watching the replay. Fourth, hold seminars on ICH guidelines and coordination topics to widely gather opinions from industry and academic experts. In 2020, the Drug Review Center held 15 domestic expert seminars on ICH, with a total of 312 participants.
　　(7) Strengthen the construction and management of the review team.
　　Strengthen the construction of the review team, smooth the career development path for reviewers, and carry out the identification of lead reviewers; improve the evaluation system for the term of appointment and strengthen the assessment work for employees; conduct supplementary recruitment to introduce urgently needed professionals in clinical, statistics, and other fields; enhance employee training, organize a series of lectures, practical training, and English speaking training on the "Drug Registration Management Measures" and supporting documents.
　　9. Strengthen service guidance, improve work efficiency and style.
　　In 2020, the Drug Review Center continuously strengthened its work style and actively served the new requirements for high-quality drug development.
　　First, closely focus on the overall situation of COVID-19 prevention and control, innovatively carry out emergency review and approval, strengthen review service guarantees, and do a good job in all aspects of the review process for COVID-19 vaccines. In response to the urgent demand for COVID-19 vaccines due to the pandemic, the Drug Review Center adhered to scientific principles, established an early intervention, continuous tracking, proactive service, and collaborative review mechanism, maintaining 24-hour communication with enterprises. No matter how late it was, even at 3-4 AM, feedback on the demands of R&D enterprises was provided immediately. The center strengthened its responsibilities in promoting overseas clinical trials and enhanced efficiency in innovative review and approval, successfully and efficiently promoting the conditional approval of the China National Pharmaceutical Group's COVID-19 vaccine and the entry of five vaccine varieties into Phase III clinical trials, ensuring that China's COVID-19 vaccines lead the world and providing timely and strong support for the overall situation of epidemic prevention and control. At the same time, it implemented General Secretary Xi Jinping's important instructions on integrating traditional Chinese and Western medicine and using both Chinese and Western drugs, actively connecting with the production enterprises and R&D units of the "three drugs and three parties" used in clinical treatment, and providing technical guidance for the registration and clinical trial applications of effective traditional Chinese medicine formulations to ensure that traditional Chinese medicine is used promptly for the treatment of COVID-19 patients. These achievements not only ensured the emergency needs for epidemic prevention but also prepared important strategic resources for normalized epidemic prevention and control, boosted the confidence of the Chinese people in overcoming the epidemic, and contributed China's strength to global epidemic prevention and control.
　　Second, strengthen communication and exchanges with applicants. Under the normalized situation of COVID-19 prevention and control, fully implement joint prevention and control measures, minimize personnel movement and gatherings, block the channels for epidemic transmission, and effectively ensure the life safety and health of applicants. While suspending on-site consultation services, telephone consultation services were opened. Eight contact email addresses were added, allowing applicants to consult questions via email and provide information such as the acceptance number of the reviewed varieties. Project management personnel will contact the relevant applicants within three working days. By continuously enriching and expanding communication channels and methods, we serve and facilitate applicants; to encourage innovation and better reflect the service attributes of communication, in conjunction with the "Drug Registration Management Measures," we revised and released the "Management Measures for Communication and Exchange in Drug R&D and Technical Review" based on the laws of drug development and registration requirements, adhering to the principle of serving drug registration applicants. The II-type meetings were categorized into three types: those that must be communicated according to law, those that should generally be communicated, and those that can be communicated, with clear and detailed requirements for each type of communication. To improve the predictability and efficiency of communication application processing, the Drug Review Center continuously optimized communication management, refined the control of time limits for each link, ensuring that applicants could quickly enjoy high-quality communication services, striving to meet the increasing communication needs of applicants year by year, raising the volume of communication application processing in 2020 to 1.31 times that of 2019, which is also 11.35 times that of 2016.
　　Third, continuously improve internal work style and enhance work efficiency. This year, the Drug Review Center continued to deepen the reform of the review and approval system, continuously optimize the review process, strictly manage time limits, implement a review task analysis meeting system, strengthen project supervision, encourage drug innovation, and promote the high-quality development of generic drugs. The quality and efficiency of reviews have greatly improved, and the overall on-time completion rate of review tasks in 2020 reached a historical high. The predictability of drug review and approval has further increased, successfully completing the reform goals related to drug review and approval in the "13th Five-Year Plan for Drug Safety." Through five years of unremitting efforts to deepen the reform of the drug review and approval system, the Drug Review Center has achieved a leap from quantitative to qualitative change, significantly shortening the average review time for drugs, greatly enhancing review capacity, and approving a large number of innovative drugs and urgently needed clinical drugs. A total of 445 varieties have passed or been deemed to have passed consistency evaluation reviews, laying a solid foundation for the development of drug review work in the "14th Five-Year Plan."
　　The Drug Review Center will deeply sort out the experiences and practices in improving review efficiency and innovating review methods, so that temporary measures under emergency conditions can be orderly elevated to a long-term mechanism for normalized review work, transforming passively chosen but practically proven long-term effective methods into proactive choices for improving review capacity under normalized conditions.
　　10. Increase the transparency of drug review and approval information.
　　The Drug Review Center continues to promote the transparency of technical review information, increasing the transparency of drug review and approval work. First, improve the information disclosure system, releasing the "Management Measures for Information Disclosure in Drug Review and Approval," clarifying the scope, types, and time limits for information disclosure, providing a system basis for good information disclosure work. Second, vigorously promote the disclosure of new drug technical review reports. Since the start of this work, 316 new drug technical review reports have been disclosed, guiding industry R&D and better serving drug registration applicants and the public. Third, increase the transparency of the technical review process by further disclosing review queue information, priority review status information, communication application and processing information, etc., on the Drug Review Center's website. A new column for "Breakthrough Therapy Publicity" has been added, disclosing information such as "proposed breakthrough therapy varieties and dissent verification results." This facilitates applicants in querying information, further broadening communication channels for applicants, responding promptly to social concerns, and increasing the transparency of review and approval work.
　　11. Key work arrangements for 2021.
　　In 2020, drug review work made certain progress, but there are still some issues: first, the number of registration applications, especially for innovative drugs, has been increasing year by year, leading to an imbalance between the scale structure of the review team and the volume of review tasks; second, difficulties in attracting high-level and urgently needed professionals, and the urgent need for long-term professional training for new reviewers highlight the shortcomings in modernizing review capabilities; third, during the transition period of old and new registration-related regulations, timely research on issues and corresponding solutions are needed. In 2021, the Drug Review Center will closely follow the work deployment of the National Medical Products Administration and focus on carrying out the following work:
　　(1) Actively promote the construction of the institutional system.
　　Improve the supporting documents for the new "Drug Registration Management Measures", ensure a smooth transition between old and new registration regulations, and handle historical issues prudently; continue to develop a scientific management system oriented towards drug review processes, establish a long-term operational mechanism, improve the system of technical guidance principles for drugs, standardize the construction of the center's institutional system, and promote the modernization of the review system and review capabilities; deeply advance regulatory science research, deepen cooperation with universities and research institutions, and accelerate the transformation of research results from the first batch of key projects.
　　(2) Make no relaxation in emergency review and approval work.
　　Always maintain an emergency work state, improve the linkage mechanism between research and review, adhere to special handling for special cases, and promote the research and development of COVID-19 treatment drugs, including traditional Chinese medicine and antibody drugs; continue to coordinate emergency review and approval verification and inspection work; continue to strengthen service guidance, continuously follow up on the progress of various technical routes for COVID-19 vaccine research and development, strictly review according to laws and regulations, and continue to carry out the review work for COVID-19 treatment drugs and COVID-19 vaccines; comprehensively summarize the experience of emergency review and approval work, improve the review and approval system, and further stimulate the vitality of drug innovation and development.
　　(3) Accelerate the establishment of a review mechanism system for traditional Chinese medicine that meets its characteristics.
　　Construct a review evidence system that combines the theory of traditional Chinese medicine, human experience with traditional Chinese medicine, and clinical trials; establish an expert review committee for ancient classic prescriptions of traditional Chinese medicine compound preparations, and solidly promote the reform of traditional Chinese medicine review and approval; reference the experience of "three-party" review and approval, gradually explore review guidance principles and standards suitable for ancient classic prescriptions of traditional Chinese medicine compound preparations, and improve technical guidance principles that meet the characteristics of traditional Chinese medicine; accelerate the approval of new traditional Chinese medicine with clinical value, and leverage the unique advantages of traditional Chinese medicine in disease prevention and treatment.
　　(4) Continue to deepen the reform of the review and approval system.
　　Consolidate the achievements of timely review reform, improve the project management work mechanism; improve the expert consultation committee system to resolve major controversial issues, use inspection rectification requirements to promote institutional reform, increase the transparency of review and approval information, optimize communication and exchange systems, and improve review service levels; refine the technical requirements for changes in marketed drugs, guide drug marketing authorization holders to conduct post-marketing continuous research; further strengthen the safety evaluation during clinical trials and the drug vigilance system construction; continue to promote the implementation of ICH guidance principles domestically; accelerate the digital construction of reviews and promote the use of the eCTD system. Accelerate the construction of an information database for research and production entities.
　　(5) Adhere to encouraging drug research and development innovation.
　　Continue to improve the drug review and approval system, adhere to safety and effectiveness as the fundamental standard, optimize the allocation of review resources, and explore the implementation of methods such as "early intervention", "research-review linkage", "parallel inspection", and "pre-inspection" in innovative drug reviews; continue to encourage the research and development innovation of new and good drugs, strengthen communication and exchange, prioritize resource allocation, further refine and implement accelerated review procedures for breakthrough therapeutic drugs, conditional approvals, priority reviews, special approvals, etc., and speed up the market launch of urgently needed foreign new drugs, rare disease drugs, pediatric drugs, and major infectious disease drugs.
　　(6) Promote the high-quality development of generic drugs.
　　Continue to improve the selection of reference formulations for generic drugs, adhere to the principle of not lowering standards, and steadily and orderly promote the consistency evaluation of quality and efficacy for generic drugs; further improve the technical guidance principles and standard system construction related to generic drugs; based on establishing a review key point system, promote the scientific standardization of generic drug reviews, and improve the quality and efficiency of generic drug reviews.
　　(7) Optimize talent team construction.
　　According to the unified deployment of the National Medical Products Administration, fully guide and promote the construction of two sub-centers in the Yangtze River Delta and the Greater Bay Area; take professional training as a starting point to further strengthen the capacity building of the drug review team; cooperate with drug review business, actively carry out personnel recruitment work, and strengthen team building; further strengthen the construction of professional technical teams, improve the promotion system for professional technical teams, etc.; further tighten personnel recruitment conditions, standardize personnel resignation, and strictly manage the team.
　　12. Conclusion
　　With the wind rising, the great roc soars to 90,000 miles. The year 2021 marks the beginning of the implementation of the "14th Five-Year Plan". The Drug Review Center, under the strong leadership of the National Medical Products Administration, will adhere to the guidance of Xi Jinping's Thought on Socialism with Chinese Characteristics for a New Era, fully implement the spirit of the 19th National Congress of the Communist Party of China and the second, third, fourth, and fifth plenary sessions of the 19th Central Committee, uphold the people-centered development philosophy, and follow the requirements of establishing a new development stage, implementing a new development concept, and constructing a new development pattern. We will adhere to General Secretary Xi Jinping's "four strictest" requirements as the fundamental guideline, focus on encouraging innovation to promote the high-quality development of drugs, deepen the reform of the drug review and approval system as the main line, meet the people's growing needs for a better life as the fundamental purpose, and build an international, modern, and scientific drug review institution as the fundamental driving force. We will fulfill our responsibilities for the country and the people, effectively ensure the safety, effectiveness, and accessibility of drugs, protect and promote public health, and strive to achieve a good start and a good step in the development during the "14th Five-Year Plan" period, welcoming the 100th anniversary of the founding of the Communist Party of China with outstanding achievements.