2019 was a milestone year in the history of drug regulation law construction. The newly formulated Vaccine Administration Law is the world's first comprehensive vaccine management law, and the revised Drug Administration Law is a comprehensive revision in nearly 20 years. The Vaccine Administration Law and the Drug Administration Law have solidified the deployment of the Party Central Committee and the State Council, the expectations of the people, and the experiences of the reform of the review system into law, providing strong legal protection for consolidating and advancing the reform of the drug review and approval system. In this year, 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 Administration) earnestly studied and implemented the Drug Administration Law and the Vaccine Administration Law, continuously promoted the reform of the drug review and approval system, actively constructed a scientific management system for drug review oriented towards processes, adhered to the principles of legality, regulation, openness, transparency, service-oriented, and scientific standardization in review, effectively ensuring the safety, efficacy, and accessibility of drugs, and safeguarding the health rights and interests of the people.

I. Acceptance of Drug Registration Applications
In 2019, the Drug Evaluation Center accepted 8,082 new registration applications (including 5 combination products), of which 6,199 required technical review (including 4,907 that required technical review and administrative approval from the Drug Evaluation Center), and 1,878 were directly administratively approved (no technical review required).

(1) Overall Situation
Among the 8,077 drug registration applications accepted by the Drug Evaluation Center, the number of chemical drug registration applications was 6,475, accounting for 80.2% of all registration applications accepted in 2019. For details on the acceptance of various drug registration applications from 2016 to 2019, see Figure 1.

Figure 1 Acceptance of Various Drug Registration Applications from 2016 to 2019
Note: 1. The acceptance volume in 2019 includes 5 registration applications for combination products, so the total number of registration applications accepted in 2019 in the above figure is greater than the sum of traditional Chinese medicine, chemical drugs, and biological products;

2. The Drug Evaluation Center's direct administrative approval work began in 2017, so there were no direct administrative approval registration applications in 2016, and all accepted registration applications required technical review.

Figure 2 Acceptance of Various Drug Registration Applications Requiring Technical Review from 2017 to 2019

In 2019, 6,199 registration applications requiring technical review were accepted, an increase of 11.21% compared to 2018, of which 4,937 were chemical drug registration applications, an increase of 10.72% compared to 2018, accounting for 79.64% of all registration applications requiring technical review; 257 were traditional Chinese medicine registration applications, a decrease of 14.33% compared to 2018; and 1,005 were biological product registration applications, an increase of 23.3% compared to 2018. For details on the acceptance of chemical drugs, traditional Chinese medicine, and biological product registration applications requiring technical review from 2016 to 2019, see Figure 2.
The Drug Evaluation Center accepted a total of 700 Class 1 innovative drug registration applications (319 varieties), with the number of varieties increasing by 20.8% compared to 2018. Among them, 302 new drug clinical trial (IND) applications for Class 1 innovative drugs were accepted, an increase of 26.4% compared to 2018; 17 new drug marketing applications (NDA) for Class 1 innovative drugs were accepted, a decrease of 8 varieties compared to 2018.

(2) Acceptance of Domestic Innovative Drug Applications
The Drug Evaluation Center accepted 528 domestic Class 1 innovative drug registration applications (244 varieties), including 503 clinical applications (228 varieties) and 25 marketing applications (16 varieties). By drug type, there were 401 chemical drugs (144 varieties) and 127 biological products (100 varieties), with the indications of innovative drugs mainly concentrated in the fields of anti-tumor, anti-infection, and digestive system diseases.

(3) Acceptance of Imported Innovative Drugs and Original Research Drugs
The Drug Evaluation Center accepted 157 registration applications for imported original research chemical drugs of Category 5.1 (92 varieties) and 172 registration applications for imported innovative drugs (75 varieties), with the indications of innovative drugs mainly concentrated in the fields of anti-tumor, endocrine, and nervous system diseases.

(4) Acceptance of Various Registration Applications

1. Acceptance of Chemical Drug Registration Applications
The Drug Evaluation Center accepted 6,475 chemical drug registration applications, including 694 IND applications for chemical drugs, an increase of 51.9% compared to 2018; 130 NDA applications for chemical drugs, an increase of 21.5% compared to 2018; 1,047 ANDA applications for generic drugs, an increase of 6.6% compared to 2018; and 1,038 supplementary applications for consistency evaluation (308 varieties), with the number increasing by 71% compared to 2018. For details on the acceptance of various chemical drug registration applications in 2019, see Figure 3. For details on the acceptance of chemical drug IND applications, NDA, and consistency evaluation from 2016 to 2019, see Figure 4.

Figure 4 Acceptance of Chemical Drug IND Applications, NDA, and Consistency Evaluation from 2016 to 2019

Registration Application Acceptance Situation
Note: The Drug Evaluation Center began to undertake the work of evaluating the quality and efficacy consistency of generic drugs in August 2017.

(1) Acceptance of Domestic and Imported Chemical Drug IND Applications and NDA

Figure 5 Distribution of Treatment Areas for Domestic and Imported Chemical Drug IND Applications and NDA Accepted in 2019

Among the chemical drug IND applications, 444 domestic chemical drug IND applications were accepted, and 250 imported IND applications were accepted. The indications of domestic chemical drug IND applications were mainly concentrated in the fields of anti-tumor, digestive system, and anti-infection drugs, while the indications of imported IND applications were mainly concentrated in the fields of anti-tumor, anti-infection drugs, and nervous system.
In the chemical drug NDA, 45 domestic chemical drug NDA applications were accepted, and 85 imported chemical drug NDA applications were accepted. The indications of domestic chemical drug NDA applications were mainly concentrated in the fields of anti-tumor and anti-infection drugs, while the indications of imported chemical drug NDA applications were mainly concentrated in the fields of anti-tumor and nervous system. For details on the distribution of treatment areas for domestic and imported chemical drug IND applications and NDA accepted in 2019, see Figure 5.

(2) Acceptance of Class 1 Chemical Drug Innovative Applications
The Drug Evaluation Center accepted 573 Class 1 chemical drug innovative registration applications (219 varieties), with the number of varieties increasing by 39.5% compared to 2018, among which 206 IND applications were accepted, an increase of 46.1% compared to 2018; 13 NDA applications were accepted, a decrease of 3 compared to 2018.

Figure 6 Acceptance of Chemical Drug Innovative Registration Applications from 2016 to 2019

Among the 219 varieties of Class 1 chemical drug innovative drug registration applications, there are 144 varieties of domestic chemical drug innovative drug registration applications and 75 varieties of imported chemical drug innovative drug registration applications. For details on the acceptance of innovative drug registration applications from 2016 to 2019, see Figure 6.

2. Acceptance of Traditional Chinese Medicine registration applications
The Drug Review Center accepted 423 Traditional Chinese Medicine registration applications, including 17 Traditional Chinese Medicine IND applications, 3 Traditional Chinese Medicine NDA applications, and 3 Traditional Chinese Medicine ANDA applications. For details on the acceptance of various types of Traditional Chinese Medicine registration applications in 2019, see Figure 7. For details on the acceptance of Traditional Chinese Medicine IND, NDA, and ANDA applications from 2016 to 2019, see Figure 8.

Figure 7 Acceptance of various types of Traditional Chinese Medicine registration applications in 2019

Figure 8 Acceptance of Traditional Chinese Medicine IND, NDA, and ANDA applications from 2016 to 2019

(1) Acceptance of Traditional Chinese Medicine IND applications
Among the 17 Traditional Chinese Medicine IND applications (categories 5, 6, and 8), the main therapeutic areas are concentrated in digestion, respiration, and orthopedics, accounting for 76% of all Traditional Chinese Medicine IND applications.

(2) Acceptance of new Traditional Chinese Medicine applications
The Drug Review Center accepted 18 registration applications for Class 5-6 new Traditional Chinese Medicines (18 varieties, with no Class 1-4 Traditional Chinese Medicine registration applications), including 15 Traditional Chinese Medicine IND applications (15 varieties) and 3 Traditional Chinese Medicine NDA applications (3 varieties), all of which have decreased compared to 2018.

3. Acceptance of biological product registration applications

Figure 9 Acceptance of various types of biological product registration applications in 2019

The Drug Review Center accepted 1179 biological product registration applications, including 310 biological product IND applications (7 preventive IND applications and 303 therapeutic IND applications), an increase of 4% compared to 2018; 124 biological product NDA applications (7 preventive NDA applications and 117 therapeutic NDA applications), an increase of 45.9% compared to 2018. For details on the acceptance of various types of biological product registration applications in 2019, see Figure 9. For details on the acceptance of biological product IND applications and NDA applications from 2016 to 2019, see Figure 10.

Figure 10 Acceptance of biological product IND applications and NDA applications from 2016 to 2019

(1) Acceptance of Class I biological product innovative drug applications
The Drug Review Center accepted 127 Class I biological product innovative drug registration applications (100 varieties), an increase of 3.3% compared to 2018, including 2 preventive biological products and 125 therapeutic biological products. Among the Class I biological product innovative drug registration applications, there are 121 IND applications (96 varieties), an increase of 8% compared to 2018; 6 NDA applications (4 varieties, all therapeutic biological products), a decrease of 5 applications compared to 2018.

Figure 11 Distribution of therapeutic areas for Class I therapeutic biological product IND applications accepted in 2019

The Drug Review Center accepted 119 Class I therapeutic biological product IND applications (95 varieties), with the main indications concentrated in the field of anti-tumor treatment, accounting for 69% of all Class I therapeutic biological product IND applications. For specific therapeutic area distribution, see Figure 11.

II. Review and approval status of drug registration applications

 

(1) Overall completion status

 

1. Completion status of review and approval for the whole year
From 2015 to 2018, the Drug Review Center expanded review channels, strengthened project management, recruited personnel on a large scale, and borrowed personnel from provincial bureaus to enhance review capacity and improve review efficiency, effectively resolving the backlog of drug registration applications. The focus of the Drug Review Center's work has gradually shifted from resolving the backlog of drug registration applications to improving the timely review and approval rate of drug registration applications. In 2019, the Drug Review Center achieved a timely review and approval rate of over 90% for various types of registration applications for Traditional Chinese Medicine, chemical drugs, and biological products, essentially completing the work goal set by the State Council in the document "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices" (Guo Fa [2015] No. 44, hereinafter referred to as Document No. 44) to achieve timely approval by 2018.
In 2019, a total of 8730 registration applications were completed (including 5 device combination products), of which 6817 registration applications requiring technical review were completed (including 4075 registration applications requiring technical review and administrative approval from the Drug Review Center), and 1908 registration applications were completed through direct administrative approval. By the end of 2019, the number of registration applications under review and awaiting review had decreased from nearly 22000 in September 2015 to 4423 (excluding applications awaiting responses from applicants due to deficiencies in submitted materials), consolidating the reform results required by Document No. 44 to resolve the backlog of registration applications.
Among the 4423 registration applications under review and awaiting review in 2019, 3334 applications were initiated for review, 450 applications were completed and awaiting verification, and 639 tasks were in situations such as suspended review waiting for related varieties (290), waiting for applicants to verify quality standard descriptions and packaging labels (235), and waiting for inspection reports (36).
Among the 6817 registration applications that completed technical review, there were 300 Traditional Chinese Medicine registration applications, 1104 biological product registration applications, and 5413 chemical drug registration applications, with chemical drug registration applications accounting for approximately 79% of the total review completion.

2. Completion status of review for various types of registration applications

Figure 12 Completion status of review for various types of registration applications from 2016 to 2019

Note: The 2019 total registration applications include 5 device combination products, hence the total number of registration applications in 2019 is greater than the sum of Traditional Chinese Medicine, chemical drugs, and biological product registration applications.
The Drug Review Center completed the review of 1001 IND applications (including 1 device combination product), 270 NDA reviews (including 1 device combination product), and 1664 ANDA reviews (including 3 drug-device combination products). For details on the completion status of various types of registration applications from 2016 to 2019, see Figure 12.

3. Review approval status
In 2019, the Drug Review Center approved 926 IND applications, 164 NDA applications, 654 ANDA applications, and approved 260 applications for consistency evaluation of oral solid preparations (counting 95 varieties by active ingredient and 107 varieties by generic name, see Appendix 1), with the number of varieties increasing by 66.7% compared to 2018 (57 varieties).
Approved 10 varieties of Class I innovative drugs for market launch, and approved 58 varieties of imported original drugs (including new indications), for specific varieties see Appendices 2 and 3.

(2) Completion status of review for chemical drug registration applications

1. Overall status

Figure 13 Completion status of the review of various chemical drug registration applications in 2019

The Drug Review Center completed the review of 5,413 chemical drug registration applications, including 746 clinical applications (IND applications and confirmatory clinical trials), 156 NDA applications, and 1,655 ANDA applications. For detailed completion status of the review of various chemical drug registration applications in 2019, see Figure 13.

2. Review Approval Status

Figure 14 Number of approved NDA reviews for chemical drugs from 2016 to 2019

Table 1 Specific completion status of the review of various chemical drug registration applications in 2019

 

Application Type	Completion of Review (cases)
	Approved/Approval	Recommended for disapproval/Disapproved	Others	Total
	(including those approved after supplementary materials were provided)
INDApplicationPlease	599	18	4	621
Confirmatory Clinical	104	7	14	125
NDA	88	3	65	156
ANDA	654	71	930	1655
Supplementary Application	1309	85	423	1817
Re-registration of Imported Drugs	387	6	76	469
Consistency Evaluation	260	17	282	559
Re-examination	/			11
Total	/			5413

Note: 'Others' refers to registration applications voluntarily withdrawn by the applicant, registration applications that have completed review and are waiting for the applicant to supplement and improve the declaration materials, registration applications submitted to the National Bureau of Drug Registration Management Department that are not reviewed by the Drug Review Center, drug-device combination registration applications sent to the National Bureau of Medical Device Technology Review Center, and registration applications for raw materials/excipients related to withdrawn formulations, etc.
The Drug Review Center completed the review of 156 NDA applications for chemical drugs, of which 88 were approved. For the number of approved NDA reviews for chemical drugs from 2016 to 2019, see Figure 14, and for the specific completion status of the review of various chemical drug registration applications in 2019, see Table 1.
The Drug Review Center completed the review of 621 IND applications for chemical drugs, approving 599 IND applications, including 493 approved IND applications for Class 1 chemical innovative drugs (189 varieties). For the number of approved IND applications for Class 1 chemical innovative drugs from 2016 to 2019, see Figure 15.

Figure 15 Number of approved IND applications for Class 1 chemical innovative drugs from 2016 to 2019

Among the 189 Class 1 chemical innovative drugs approved for IND applications by the Drug Review Center, there are many anti-tumor drugs, digestive system disease drugs, anti-infection drugs, and nervous system disease drugs, accounting for 70% of the total number of approved clinical trials for innovative drugs. For the distribution of indications for Class 1 chemical innovative drugs approved for IND applications in 2019, see Figure 16.

Figure 16 Distribution of indications for Class 1 chemical innovative drugs approved for IND applications in 2019

Note: Some chemical innovative drugs have multiple indications distributed across different indication groups, so the sum of the number of innovative drug varieties in each indication group in the above figure is greater than 189.

(3) Completion status of the review of traditional Chinese medicine registration applications

1. Overall status
The Drug Review Center completed the review of 300 traditional Chinese medicine registration applications, including 17 IND applications, 3 NDA applications, and 6 ANDA applications. For the completion status of the review of various traditional Chinese medicine registration applications in 2019, see Figure 17.

Figure 17 Completion status of the review of various traditional Chinese medicine registration applications in 2019

2. Review Approval Status

Figure 18 Number of approved IND applications and NDA reviews for traditional Chinese medicine from 2016 to 2019

The Drug Review Center approved 15 traditional Chinese medicine IND applications and 2 traditional Chinese medicine NDA applications (2 varieties: Shao Ma Zhi Jiao Granules, Xiao Er Jing Xing Zhi Ke Granules). For the specific completion status of the review of various traditional Chinese medicine registration applications in 2019, see Table 2, and for the number of approved IND applications and NDA reviews for traditional Chinese medicine from 2016 to 2019, see Figure 18.

Table 2 Specific completion status of the review of various traditional Chinese medicine registration applications in 2019

Application Type	Completion of Review (cases)
	Approved/Approval	Recommended for disapproval/	Others	Total
	(including those approved after supplementary materials were provided)	Disapproved
INDApplication	15	2	0	17
NDA	2	0	1	3
ANDA	0	5	1	6
Supplementary Application	195	2	51	248
Re-registration of Imported Drugs	6	0	7	13
Re-examination	/			13
Total	/			300

The Drug Review Center approved 15 traditional Chinese medicine IND applications, covering 10 therapeutic areas, with 2 each in cardiovascular, digestive, oncology, respiratory, and renal fields, accounting for 67%. For specific distribution in therapeutic areas, see Figure 19.

Figure 19 Distribution of Traditional Chinese Medicine IND Applications Approved in 2019

(4) Status of Biological Product Registration Application Review

1. Overall status

The Drug Review Center completed the review of a total of 1104 biological product registration applications, including 24 for preventive biological product IND applications, 338 for therapeutic biological product IND applications, 13 for preventive biological product NDA, 95 for therapeutic biological product NDA, and 2 for in vitro diagnostic reagent NDA. For the review completion status of various biological product registration applications in 2019, see Figure 20.

Figure 20 Review Completion Status of Various Biological Product Registration Applications in 2019

2. Review Approval Status
The Drug Review Center approved 18 preventive IND applications and 294 therapeutic IND applications, as well as 5 preventive NDAs, 67 therapeutic NDAs, and 2 in vitro diagnostic NDAs. For specific completion status of various biological product registration applications in 2019, see Table 3, and for the number of IND applications approved and NDA reviews completed from 2016 to 2019, see Figure 21.

Table 3 Specific Completion Status of Various Biological Product Registration Applications in 2019

Application Type	Completion of Review (cases)
	Approved/Approval	Recommended for disapproval/	Others	Total
	(including those approved after supplementary materials were provided)	Disapproved
PreventiveINDApplication	18	3	3	24
TherapeuticINDApplication	294	31	13	338
PreventiveNDA	5	1	7	13
TherapeuticNDA	67	2	26	95
In Vitro Diagnostic ReagentsNDA	2	0	0	2
Supplementary Application	361	14	177	552
Re-registration of Imported Drugs	62	1	14	77
Re-examination	/			3
Total	/			1104

Figure 21 Number of Biological Product IND Applications Approved and NDA Reviews Completed from 2016 to 2019

The Drug Review Center approved 312 biological product IND applications, with the distribution in therapeutic areas detailed in Figure 22.

Figure 22 Distribution of Approved Biological Product IND Applications in 2019

The Drug Review Center approved 74 biological product NDAs, with the distribution in therapeutic areas detailed in Figure 23.

Figure 23 Distribution of Approved Biological Product NDAs in 2019

(5) Status of Administrative Approval Registration Applications

1. Overall status

In 2019, the Drug Review Center completed 5983 administrative approval registration applications for traditional Chinese medicine, chemical drugs, and biological products, including 4075 registration applications that completed review and approval (clinical trial applications, consistency evaluations, supplementary applications, re-registration applications for imported drugs, and re-examinations), and 1908 registration applications that completed direct administrative approval (supplementary applications and temporary import applications that do not require technical review).

2. Review and Approval Completion Status
Among the 4075 registration applications that required review and approval by the Drug Review Center, there were 1124 clinical trial applications (including verification clinical trials), 345 consistency evaluations, 2127 supplementary applications, 471 re-registration applications for imported drugs, and 8 re-examinations. According to the 60-day implied approval system for clinical trials, the Drug Review Center issued 1178 clinical trial notification letters after completing the review and approval, including 1066 'Clinical Trial Notification Letters' and 112 'Suspension of Clinical Trial Notification Letters'. Since ANDA and other registration applications require applicants to supplement clinical trials during the technical review process, the number of clinical trial notification letters issued exceeds the 1124 clinical trial applications that required review and approval by the Drug Review Center.

3. Direct Administrative Approval Completion Status
Among the 1908 direct administrative approval registration applications reviewed by the Drug Review Center, there were 1491 supplementary applications and 417 temporary import applications.
The average approval time for the 1908 direct administrative approval registration applications by the Drug Review Center was 9.9 working days, with 1905 applications completed within the statutory 20-day limit, resulting in an annual average on-time completion rate of 99.8%.

(6) Priority Review Status

1. Inclusion of Priority Review Varieties
According to the former National Food and Drug Administration's 'Opinions on Resolving the Backlog of Drug Registration Applications by Implementing Priority Review and Approval' (Food and Drug Administration Drug Chemical Management [2016] No. 19) and 'Opinions on Encouraging Drug Innovation by Implementing Priority Review and Approval' (Food and Drug Administration Drug Chemical Management [2017] No. 126), in 2019, the Drug Review Center included 253 registration applications (counting 139 varieties by generic name) in the priority review process, a year-on-year decrease of 19.2%, including 52 for pediatric medications and rare disease medications. For the status of various registration applications included in the priority review process from 2016 to 2019, see Table 4.

Table 4 Status of Registration Applications Included in the Priority Review Process from 2016 to 2019

Status of Registration Applications Included in the Priority Review Process	2016Year		2017Year		2018Year		2019Year
	Task (pieces)	Proportion	Task (pieces)	Proportion	Task (pieces)	Proportion	Task (pieces)	Proportion
New drugs with significant clinical value	85	44.00%	106	46.10%	72	23.00%	86	34.00%
Synchronous declaration	19	9.80%	36	16.00%	86	27.50%	71	28.10%
Rare diseases	8	4.10%	11	5.00%	28	8.90%	28	11.10%
Pediatric medication	17	9.00%	30	13.00%	35	11.20%	24	9.50%
Re-declare after improving according to the standards consistent with the quality and efficacy of the original drug	——	——	10	4.00%	52	16.60%	20	7.90%
Major special projects	——	——	——	——	15	4.80%	19	7.50%
Patent expiration	16	8.00%	18	8.00%	25	8.00%	4	1.60%
Clinically urgent, market shortage	5	3.00%	12	5.00%	——	——	1	0.40%
First imitation	43	22.00%	7	3.00%	——	——	——	——
Total	193	100.00%	230	100.00%	313	100.00%	253	100.00%

Note: 1. Priority review work started in 2016.
2. Proportion = various tasks of the year / total tasks, the same below.
Among the registered applications included in priority review, new drugs with significant clinical value account for 34%, the largest proportion, followed by synchronous declaration varieties (28.1%). Compared to the structure of registered applications included in priority review in 2018, the proportion of new drugs with significant clinical value increased from 23% to 34%, while the proportion of re-declared varieties improved according to the standards consistent with the quality and efficacy of the original drug decreased from 16.6% to 7.9%. From the data changes, the number of generic drugs is gradually decreasing, and priority review resources are focusing more on drugs with significant clinical value, clinical urgency, and clinical advantages.

2. Completion status of priority review varieties
In 2019, 143 registration applications (counting 82 varieties by generic name) passed the priority review process and were expedited for approval, such as the domestically developed class 1 innovative drug injection of remimazolam tosilate, mannitol capsules, injection of agalsidase beta for treating the rare disease Fabry disease, the RANKL inhibitor denosumab injection for treating diabetes, the polyethylene glycol loxenatide injection for treating psoriasis, and the targeted therapy drug dacomitinib tablets for non-small cell lung cancer. The details of the priority review varieties in recent years are shown in Table 5, and the specific list of varieties can be found in Appendix 4.

Table 5: Status of varieties approved for priority review from 2016 to 2019

Varieties approved for priority review	2016Year		2017Year		2018Year		2019Year
	Variety (pieces)	Proportion	Variety (pieces)	Proportion		Variety (pieces)	Proportion	Variety (pieces)	Proportion
New drugs with significant clinical value	1	14.30%	33	66.00%		39	47.00%	40	48.80%
Synchronous declaration	——	——	4	8.00%		14	16.90%	7	8.50%
Rare diseases	——	——	——	——		3	3.60%	6	7.30%
Pediatric medication	4	57.10%	1	2.00%		9	10.80%	7	8.50%
Re-declare after improving according to the standards consistent with the quality and efficacy of the original drug	——	——	——	——		5	6.00%	8	9.80%
Major special projects	——	——	——	——		——	——	5	6.10%
Patent expiration	1	14.30%	2	4.00%		4	4.80%	7	8.50%
Clinically urgent, market shortage	——	——	2	4.00%		3	3.60%	——	——
First imitation	1	14.30%	8	16.00%		6	7.20%	2	2.40%
Total	7	100.00%	50	100.00%		83	100.00%	82	100.00%

 

(7) Communication and Exchange Situation 1. Overall Situation In order to further strengthen service awareness and provide convenient guidance and services for applicants in research and innovation, the Drug Review Center continuously enriches communication channels and improves the efficiency and quality of communication. A multi-channel and multi-level communication model has been formed, including communication meetings, general technical issue consultations, telephone consultations, email consultations, and on-site consultations. In 2019, the Drug Review Center received 2,633 applications for communication meetings, an increase of 32.8% compared to 2018, and processed 1,871 applications for communication meetings, an increase of 41.1% compared to 2018. To ensure the quality of meetings and improve meeting efficiency, the Drug Review Center strictly screened applications before meetings according to the relevant requirements of the National Bureau's announcement on the management measures for communication and exchange in drug research and technical review (Announcement No. 74 of 2018), eliminating applications with issues such as duplicate submissions and lack of valid meeting materials. Approved meeting applications are held as soon as possible within the required time frame. For applications that do not require a meeting, the Drug Review Center provides timely feedback to applicants in written form. In 2019, the center received 16,572 general technical issue consultations on the online platform, an increase of 8.9% compared to 2018; received over ten thousand telephone consultations, and thousands of email consultations, while also providing on-site consultation services to the public. For detailed information on the number of communication applications and general technical issue consultations received in recent years, please refer to Figure 24.