Chapter One General Principles
Article 1 In order to promote the inheritance, innovation, and development of traditional Chinese medicine (TCM), follow the research laws of TCM, strengthen the research and registration management of new TCM drugs, and formulate these regulations in accordance with the "Drug Administration Law of the People's Republic of China", "Traditional Chinese Medicine Law of the People's Republic of China", "Implementation Regulations of the Drug Administration Law of the People's Republic of China", "Drug Registration Management Measures", and other laws, regulations, and rules.
Article 2 The development of new TCM drugs should focus on reflecting the original thinking and holistic view of TCM, encourage the use of traditional TCM research methods and modern scientific technologies to research and develop TCM. Support the development of new TCM drugs based on ancient classic prescriptions, experiences from renowned TCM practitioners, and TCM preparations formulated by medical institutions (hereinafter referred to as medical institution TCM preparations) that have rich clinical practice experience in TCM; support the development of new TCM drugs that have systemic regulatory intervention functions for the human body, and encourage the application of emerging sciences and technologies to elucidate the mechanisms of action of TCM.
Article 3 The development of new TCM drugs should adhere to a clinical value-oriented approach, emphasize clinical benefits and risk assessment, leverage the unique advantages and roles of TCM in disease prevention and treatment, and focus on meeting unmet clinical needs.
Article 4 The development of new TCM drugs should comply with TCM theories, reasonably formulate prescriptions under the guidance of TCM theories, and draft functions, indications, applicable populations, dosages, treatment courses, efficacy characteristics, and medication contraindications. Encourage the observation of disease progression, syndrome transformation, symptom changes, and drug reactions in TCM clinical practice to provide supporting evidence for the development of new TCM drugs based on TCM theories.
Article 5 New TCM drugs derived from clinical practice should gradually clarify their functions, indications, applicable populations, administration plans, and clinical benefits based on summarizing individual medication experiences, forming fixed prescriptions, and developing new TCM drugs suitable for group medication. Encourage high-quality human experience research during TCM clinical practice to clarify the clinical positioning and clinical value of TCM, continuously analyze and summarize based on scientific methods, and obtain sufficient evidence to support registration.
Article 6 The registration review of TCM should adopt a review evidence system that combines TCM theories, human experience, and clinical trials to comprehensively evaluate the safety, efficacy, and quality controllability of TCM.
Article 7 The efficacy evaluation of TCM should be combined with the characteristics of TCM clinical treatment, determining efficacy outcome indicators that are compatible with the clinical positioning of TCM and reflect its characteristics and advantages. Evaluations of situations such as disease cure or delayed progression, improvement of conditions or symptoms, improvement of patient-related bodily functions or quality of life, and significant reduction of dosage of chemical drugs that enhance efficacy or reduce toxicity when used in combination with TCM can all be used for the efficacy evaluation of TCM.
Encourage the use of real-world research, new biological markers, alternative endpoint decision-making, patient-centered drug development, adaptive design, enrichment design, etc., for the efficacy evaluation of TCM.
Article 8 The safety and benefit-risk ratio of TCM should be comprehensively assessed based on the composition and characteristics of the prescription, TCM theories, human experience, clinical trials, and necessary non-clinical safety research results, strengthening the lifecycle management of TCM.
Article 9 Applicants for registration (hereinafter referred to as applicants) developing TCM should strengthen the source quality control of TCM materials and TCM pieces, conduct resource assessments, ensure traceability of TCM materials, and clarify the origin, production area, and harvesting period of the materials. Strengthen quality control throughout the production process to maintain stable and controllable inter-batch quality. TCM prescription drugs can be processed for quality uniformity before being used.
Article 10 Applicants should ensure the sustainable use of TCM material resources and pay attention to the impact on the ecological environment. Those involving endangered wild plants and animals should comply with national regulations.
 
Chapter Two Classification and Approval of TCM Registration
Article 11 The classification of TCM registration includes innovative TCM drugs, improved new TCM drugs, compound preparations of ancient classic prescriptions, and drugs with the same name and formula. The specific circumstances of TCM registration classification and the corresponding application document requirements shall be implemented in accordance with the relevant regulations on TCM registration classification and application document requirements.
Article 12 The research and development of new TCM drugs should be combined with TCM registration classification, selecting research and development paths or models that match their characteristics based on the variety. TCM drugs discovered and explored for their efficacy characteristics based on TCM theories and human experience should primarily confirm their efficacy through human experience and/or necessary clinical trials; TCM drugs determined for research based on pharmacological screening studies should undergo necessary Phase I clinical trials and sequentially conduct Phase II and Phase III clinical trials.
Article 13 The registration application for compound preparations of ancient classic prescriptions will implement simplified registration approval, and specific requirements will be executed in accordance with relevant regulations.
Article 14 The registration applications for new TCM drugs with clear clinical positioning and significant clinical value will be prioritized for review and approval in the following situations:
(1) Used for the prevention and treatment of major diseases, newly emerging infectious diseases, and rare diseases;
(2) Clinically urgently needed but in short supply in the market;
(3) Pediatric medications;
(4) Newly discovered medicinal materials and their preparations, or new medicinal parts of medicinal materials and their preparations;
(5) Medicinal substances with clear bases and basically clear mechanisms of action.
Article 15 For diseases that are life-threatening and have no effective treatment methods, as well as TCM drugs recognized as urgently needed by the National Health Commission or the competent department of TCM, if there are data from drug clinical trials or high-quality human experience evidence showing efficacy and predicting clinical value, conditional approval can be granted, and relevant matters will be noted in the drug registration certificate.
Article 16 In the event of a public health emergency, TCM drugs recognized as urgently needed by the National Health Commission or the competent department of TCM can apply for clinical trials or marketing licenses or increase functions and indications directly according to special approval procedures based on human experience evidence.
 
Chapter Three Reasonable Application of Human Experience Evidence
Article 17 Human experience with TCM is usually accumulated in clinical practice, possessing certain regularity, repeatability, and clinical value, and includes the understanding and summary of clinical positioning, applicable populations, dosages, efficacy characteristics, and clinical benefits of TCM prescriptions or preparations accumulated during the clinical medication process.
Article 18 Applicants can collect and organize human experience through multiple channels and should be responsible for the authenticity and traceability of the data. The standardized collection, organization, and evaluation of human experience should comply with relevant requirements. As key evidence supporting registration applications, human experience data will be organized and conducted by the drug supervision and management department according to relevant procedures for drug registration verification.
Article 19: Reasonable and sufficient analysis of data and correct interpretation of results based on human experience can serve as evidence to support registration applications. Applicants can determine subsequent research strategies and provide corresponding application materials based on the degree of support for drug safety and efficacy from existing human experience evidence.
Article 20: The prescription drugs used as key evidence to support registration applications must have fixed characteristics (including origin, medicinal parts, preparation methods, etc.) and their dosages. The key pharmaceutical information and quality of the submitted formulation should be consistent with the drugs used in human experience. If there are changes in the preparation process, excipients, etc., an evaluation should be conducted, and supporting research evaluation materials for the relevant changes should be provided.
Article 21: The prescriptions of innovative traditional Chinese medicine (TCM) drugs originate from ancient classic formulas or clinical experience formulas in TCM. If the composition, clinical positioning, usage, and dosage are basically consistent with previous clinical applications, and traditional processes that are consistent with clinically used drugs are adopted, and the main functions, applicable populations, administration plans, and clinical benefits can be preliminarily determined through human experience, non-clinical efficacy studies may not be required.
Article 22: Traditional Chinese medicine compound preparations composed of TCM decoction pieces generally provide data from single-dose toxicity tests and repeated-dose toxicity tests in rodents, and other toxicological test data should be provided if necessary.
If the decoction pieces in the prescription composition of the TCM compound preparation meet national drug standards or have drug registration standards, do not contain toxic medicinal ingredients, or do not include decoction pieces that have been proven to be toxic by modern toxicology and can lead to serious adverse reactions, use traditional processes, and are not used for special populations such as pregnant women and children, and if no significant toxicity is found in single-dose toxicity tests and one animal's repeated-dose toxicity tests, generally, there is no need to provide repeated-dose toxicity tests in another animal, as well as safety pharmacology, genetic toxicity, carcinogenicity, reproductive toxicity, and other test data.
The term 'toxic medicinal ingredients' in this regulation refers to the toxic TCM varieties listed in the 'Measures for the Administration of Toxic Medical Drugs'.
Article 23: For new TCM drugs derived from clinical practice, if human experience can provide research and supporting evidence in clinical positioning, applicable population selection, treatment course exploration, dosage exploration, etc., non-phase II clinical trials may not be required.
Article 24: For clinical research and development of existing human experience TCM, based on fixed prescriptions and production processes, if there is applicable high-quality real-world data, and real-world evidence formed through well-designed clinical studies is scientifically sufficient, after communicating and reaching an agreement with the national drug review agency on the real-world research plan, the applicant may apply to use real-world evidence as one of the bases for supporting product marketing.
Article 25: Medical institutions are responsible for the safety, efficacy, and quality controllability of TCM preparations in medical institutions. They should continuously and normatively collect and organize human experience data of TCM preparations in medical institutions and submit annual reports on the collection, organization, and evaluation of human experience data of TCM preparations to the provincial drug supervision and administration department.
Article 26: For new TCM drugs derived from medical institution preparations, if the prescription composition, process route, clinical positioning, usage, and dosage are basically consistent with previous clinical applications, and if human experience can preliminarily determine the main functions, applicable populations, administration plans, and clinical benefits, non-clinical efficacy studies may not be required. If the prescription composition, extraction process, dosage form, and packaging materials that directly contact the drug are consistent with the TCM preparations of that medical institution, based on the pharmaceutical research data of that medical institution's TCM preparations, there is no need to provide research data on dosage form selection, process route selection, and packaging materials that directly contact the drug.
Article 27: Applicants may communicate with the national drug review agency regarding TCM theory, human experience research plans, and human experience data based on specific varieties during key research and development stages.
 
Chapter 4: Innovative Traditional Chinese Medicine
Article 28: Innovative TCM drugs should have sufficient evidence of efficacy and safety, and randomized controlled clinical trials should generally be conducted before marketing.
Article 29: It is encouraged to explore the use of sequential combination therapy based on clinical treatment plans in innovative TCM drug clinical trials and efficacy evaluations according to TCM clinical practice.
Article 30: It is encouraged that innovative TCM drug clinical trials prioritize the use of placebo controls or placebo controls with basic treatment, provided that ethical requirements are met.
Article 31: TCM decoction pieces, extracts, etc., can all be used as components of TCM compound preparations. If they contain TCM decoction pieces or extracts without national drug standards and do not have drug registration standards, their drug standards should be attached to the formulation drug standards.
Article 32: Extracts and their preparations should have sufficient basis for the topic, and research on efficacy, safety, and quality controllability should be conducted. Reasonable preparation processes should be determined through research. The structural types of major components and the structures of main components should be clarified through research, and quality control projects such as content determination and fingerprint or characteristic maps of main components and major components should be established to fully characterize the quality of extracts and preparations, ensuring uniform and stable quality across different batches.
Article 33: For registration applications of new extracts and their preparations, if there are already single-component preparations or single-component extract preparations on the market with basically consistent functions and indications, non-clinical and clinical comparative studies should be conducted with those preparations to demonstrate their advantages and characteristics.
Article 34: For registration applications of new medicinal materials and their preparations, research data on the properties, meridian tropism, and efficacy of the medicinal materials should be provided, and relevant research should support the proposed properties, meridian tropism, and efficacy of the new medicinal materials.
Article 35: TCM compound preparations can be classified into different situations based on their indications:
(1) TCM compound preparations indicated for syndromes refer to TCM compound preparations used to treat TCM syndromes under the guidance of TCM theory, including those for treating diseases or symptoms in TCM, with functional indications expressed in professional TCM terminology;
(2) TCM compound preparations indicated for the combination of diseases and syndromes involve 'disease' referring to modern medical diseases and 'syndrome' referring to TCM syndromes, with functions expressed in professional TCM terminology and indications presented in a way that combines modern medical diseases with TCM syndromes;
(3) TCM compound preparations indicated for diseases belong to specialized medicines, formulated under the guidance of TCM theory. The 'disease' involved refers to modern medical diseases, with functions expressed in professional TCM terminology and indications presented in terms of modern medical diseases.
Article 36: Applicants for the registration of innovative TCM drugs may conduct phased research based on the characteristics of TCM and the general rules of new drug development, focusing on the main objectives of different research stages such as applying for clinical trials, phase III clinical trials, and applying for marketing authorization. The phased research of TCM pharmacy should reflect that quality originates from design concepts, emphasizing the overall and systematic nature of the research.
Article 37: Innovative traditional Chinese medicine (TCM) should be reasonably selected in terms of dosage form and administration route based on the composition of prescription drugs, medicinal properties, and clinical needs, drawing on medication experience. It should comprehensively analyze aspects such as drug production processes, physicochemical properties, traditional usage methods, biological characteristics, dosage form characteristics, safety in clinical use, and patient compliance. If oral administration is an option, injection should not be chosen.
Article 38: The development of innovative TCM should conduct corresponding non-clinical safety trials based on safety information obtained from the characteristics of the drug and clinical application situations. Non-clinical safety trials can be conducted according to different registration classifications, risk assessment situations, and development progress.
Article 39: Samples used in non-clinical safety trials should be of pilot scale or larger. When applying for clinical trials, documentation should be provided to explain the preparation of samples used in non-clinical safety trials. Generally, clinical trial drugs should use samples of production scale. When applying for market approval, documentation should be provided to explain the preparation of clinical trial drugs, including the test drug and placebo.
Article 40: The following situations should conduct necessary Phase I clinical trials:
(1) The prescription contains toxic medicinal ingredients;
(2) Except for prescriptions that have a confirmed history of use and are included in provincial TCM decoction pieces processing standards, prescriptions containing TCM decoction pieces or extracts without national drug standards and lacking drug registration standards;
(3) Non-clinical safety trial results show significant toxic reactions indicating potential safety risks to humans;
(4) TCM registration applications that require obtaining human pharmacokinetic data to guide clinical medication.
 
Chapter 5: Improved New Drugs of Traditional Chinese Medicine
Article 41: Support should be given to drug marketing authorization holders (hereinafter referred to as holders) in conducting research on improved new drugs. The research and development of improved new drugs should follow the principles of necessity, scientificity, and rationality, with clear improvement objectives. It should be based on already marketed drugs, with a comprehensive, objective, and scientific understanding of the drug being improved, focusing on the defects of the improved TCM or newly discovered therapeutic characteristics and potential during clinical application. When developing improved new drugs for children, it should comply with children's growth and development characteristics and medication habits.
Article 42: Improved new drugs that change the dosage form or administration route of already marketed TCM should have clinical application advantages and characteristics, such as improving efficacy, enhancing safety, and increasing compliance, or promoting environmental protection and improving production safety levels without reducing efficacy and safety.
Article 43: Registration applications for changing the administration route of already marketed drugs should explain the rationality and necessity of the change, conduct corresponding non-clinical research, and carry out clinical trials around the improvement objectives to demonstrate the clinical application advantages and characteristics of the changed administration route.
Article 44: Registration applications for changing the dosage form of already marketed TCM should provide sufficient evidence based on clinical treatment needs, physicochemical properties, and biological properties to explain its scientific rationality. Applicants should conduct corresponding pharmaceutical research based on the specific circumstances of the new dosage form and, if necessary, conduct non-clinical efficacy and safety studies and clinical trials.
For pediatric medications, medications for special populations (such as those with swallowing difficulties), and certain marketed TCM that are inconvenient to use due to special methods, improving clinical compliance by changing the dosage form may not require clinical trials if comparative studies show no significant changes in the medicinal substance basis and drug absorption and utilization after the change, and the original dosage form has sufficient clinical value evidence.
Article 45: For TCM that increases functional indications, except for the situations specified in Article 23 and Article 46, non-clinical efficacy research data should be provided, and Phase II and Phase III clinical trials should be conducted sequentially.
For extending the medication cycle or increasing the dosage, non-clinical safety research data should be provided. If relevant non-clinical safety research has been conducted before marketing that supports the extension of the cycle or increase in dosage, new non-clinical safety trials may not be required.
If the applicant does not hold the application for increasing functional indications for already marketed TCM, they should simultaneously submit a registration application for a drug with the same name and formula.
Article 46: For already marketed TCM applying to increase functional indications, if there is human evidence supporting the corresponding clinical positioning, non-clinical efficacy trial data may not be required. If the dosage and treatment duration do not increase, and the applicable population remains unchanged, non-clinical safety trial data may not be required.
Article 47: Encourage the use of new technologies and new processes suitable for product characteristics to improve already marketed TCM. If changes in the production process or excipients of already marketed TCM lead to significant changes in the medicinal substance basis or drug absorption and utilization, research should aim to improve efficacy or enhance safety, conducting relevant non-clinical efficacy and safety trials as well as Phase II and Phase III clinical trials, following the registration application for improved new drugs.
 
Chapter 6: Compound Preparations of Ancient Classic Formulas
Article 48: Compound preparations of ancient classic formulas that do not contain incompatible ingredients or medicinal ingredients marked as highly toxic, toxic, or proven toxic by modern toxicology should be prepared using traditional methods and administered through traditional routes, with functional indications expressed in TCM terminology. The development of such TCM compound preparations does not require non-clinical efficacy research and clinical trials. The drug approval number will be given in a special format.
Article 49: The evaluation of compound preparations of ancient classic formulas should primarily rely on expert opinions. An expert evaluation committee composed of national TCM masters, academicians, and renowned TCM practitioners will conduct technical evaluations of such preparations and provide technical evaluation opinions on whether to approve them for marketing.
Article 50: For compound preparations of TCM managed according to the directory of ancient classic formulas applying for market approval, the applicant should conduct corresponding pharmaceutical research and non-clinical safety research. The prescription composition, medicinal material origin, medicinal parts, processing specifications, calculated dosage, usage and dosage, and functional indications should generally be consistent with the key information of ancient classic formulas published by the state.
Article 51: For registration applications of other compound preparations derived from ancient classic formulas, in addition to providing corresponding pharmaceutical research and non-clinical safety trial data, key information and its basis regarding ancient classic formulas should also be provided, along with a systematic summary of TCM clinical practice to explain its clinical value. The modifications of ancient classic formulas should be conducted under the guidance of TCM theory.
Article 52 encourages applicants to communicate with national drug review agencies on major issues such as baseline sample research, non-clinical safety studies, standardized collection and organization of human experience, and summaries of traditional Chinese clinical practices during key stages of research and development based on the characteristics of ancient classic famous prescriptions of traditional Chinese medicine compound preparations.
Article 53 states that after the market launch of traditional Chinese medicine compound preparations based on ancient classic famous prescriptions, the holder should conduct post-marketing clinical research to continuously enrich and improve evidence of clinical efficacy and safety. The holder should continuously collect adverse reaction information, timely revise and improve the instructions, and promptly conduct non-clinical safety studies for unexpected adverse reactions discovered during clinical use.
 
Chapter 7: Same Name and Same Prescription Drugs
Article 54 states that the development of same name and same prescription drugs should avoid low-level duplication. Applicants should evaluate the clinical value of marketed traditional Chinese medicine that is used as a control and has the same name and prescription (hereinafter referred to as control same name and same prescription drugs). The safety, efficacy, and quality controllability of the same name and same prescription drugs applied for registration should not be lower than that of the control same name and same prescription drugs.
Article 55 states that the development of same name and same prescription drugs should conduct comparative studies with control same name and same prescription drugs in terms of quality control throughout the entire process, including traditional Chinese medicinal materials, traditional Chinese medicinal slices, intermediates, and preparations. Applicants should evaluate whether to conduct non-clinical safety studies and clinical trials based on the efficacy and safety evidence of the control same name and same prescription drugs, as well as the comparative results of the processes and excipients between the same name and same prescription drugs and the control same name and same prescription drugs.
Article 56 states that applicants should select control same name and same prescription drugs based on the results of clinical value assessment. Control same name and same prescription drugs should have sufficient evidence of efficacy and safety, and those that have been approved for marketing after conducting clinical trials according to drug registration management requirements, traditional Chinese medicines listed in the current version of the Pharmacopoeia of the People's Republic of China, and marketed traditional Chinese medicines that have obtained traditional Chinese medicine protection variety certificates can generally be considered to have sufficient evidence of efficacy and safety.
The traditional Chinese medicines referred to in the previous paragraph that have obtained traditional Chinese medicine protection certificates refer to traditional Chinese medicine protection varieties that have ended their protection period and other traditional Chinese medicine protection varieties that comply with the relevant regulations of the traditional Chinese medicine variety protection system.
Article 57 states that if the same name and same prescription drugs applied for registration need to be compared with control same name and same prescription drugs through clinical trials, at least phase III clinical trials must be conducted. Single-component traditional Chinese medicines extracted can demonstrate their consistency with control same name and same prescription drugs through bioequivalence testing.
Article 58 states that varieties with national drug standards but without drug approval numbers should apply for registration according to the same name and same prescription drugs. Applicants should conduct necessary clinical trials based on the situation of traditional Chinese medicine theory and human experience.
Article 59 states that if the control same name and same prescription drugs have sufficient evidence of efficacy and safety, and the processes and excipients of the same name and same prescription drugs are the same as those of the control same name and same prescription drugs, or if the changes in the processes and excipients of the same name and same prescription drugs do not cause significant changes in the medicinal substance basis or drug absorption and utilization after research evaluation, generally, non-clinical safety studies and clinical trials are not required.
 
Chapter 8: Post-Marketing Changes
Article 60 states that changes to marketed traditional Chinese medicines should follow the characteristics and rules of traditional Chinese medicines and meet the relevant requirements of necessity, scientificity, and rationality. The holder should fulfill the main responsibility for change research and evaluation, and change management, comprehensively assess and verify the impact of changes on the safety, efficacy, and quality controllability of the drugs. Based on research, evaluation, and relevant verification results, determine the change management category of the marketed traditional Chinese medicines, and the implementation of changes should be conducted according to regulations after approval and filing or reporting. The holder can communicate with the corresponding drug supervision and management departments in a timely manner during the post-marketing change research process.
Article 61 states that changes in drug specifications should follow the principle of corresponding to the prescription drug flavors and the principle of coordination with applicable populations, usage, dosage, and packaging specifications.
For those with existing same varieties on the market, the specifications applied for should generally be consistent with the specifications of the same varieties on the market.
Article 62 states that changes in production processes and excipients should not cause significant changes in the medicinal substances or drug absorption and utilization. The selection of production equipment should meet the requirements of production processes and quality assurance.
Article 63 states that changes in usage or dosage or an increase in the applicable population range without changing the administration route should provide non-clinical safety research data supporting the change, and clinical trials should be conducted if necessary. Except for the circumstances specified in Article 64, changes in usage or dosage or an increase in the applicable population range that require clinical trials should be conducted sequentially in phase II and phase III clinical trials.
For marketed pediatric medications where the dosage is not clearly defined, necessary clinical trials can be conducted based on the characteristics of pediatric medications and human experience to clarify the dosage and treatment duration for children of different age groups.
Article 64 states that for marketed traditional Chinese medicines applying to change usage or dosage or increase the applicable population range, if the functional indications remain unchanged and the administration route is not altered, and human experience evidence supports the new usage or dosage or new applicable population, phase II clinical trials may not be conducted, and only phase III clinical trials should be carried out.
Article 65 states that substituting or removing toxic medicinal flavors or those in a state of endangerment from the national drug standard prescription should be based on the composition and efficacy of the medicinal flavors in the prescription, and comparative studies on pharmacy, non-clinical efficacy, and/or non-clinical safety with the original drug should be conducted according to relevant technical requirements. Substituting or removing clearly toxic medicinal flavors in the prescription can conduct phase III clinical trials with a placebo control. For substituting or removing medicinal flavors in a state of endangerment in the prescription, at least phase III clinical trials comparative studies should be conducted. If necessary, the generic name of the drug should also be changed.
Article 66 states that if the main indications or applicable population range are deleted, the rationale for deleting that indication or applicable population range should be explained, and generally, clinical trials are not required.
Chapter 9: Traditional Chinese Medicine Registration Standards
 
Article 68 states that the research and formulation of traditional Chinese medicine registration standards should aim to achieve stable and controllable quality of traditional Chinese medicine, establishing control indicators that reflect the overall quality of traditional Chinese medicine based on product characteristics. It should reflect the quality status of the product as much as possible and pay attention to the relationship with the efficacy and safety of traditional Chinese medicine.
第六十八条 中药注册标准的研究、制定应当以实现中药质量的稳定可控为目标，根据产品特点建立反映中药整体质量的控制指标。尽可能反映产品的质量状况，并关注与中药有效性、安全性的关联。
Article 69: Support the use of new technologies and methods to explore the establishment of fingerprint or characteristic maps for quality control of intermediates and formulations of traditional Chinese medicine (TCM) new drugs, as well as biological effect detection, etc. The detection items such as content determination in the TCM registration standards should have a reasonable range.
Article 70: Based on product characteristics and actual conditions, the holder should establish internal control standards that are not lower than the TCM registration standards, and continuously revise and improve inspection items, methods, limits, etc., to enhance the quality of TCM formulations.
Article 71: After the drug is marketed, production data should be accumulated, and in conjunction with the development of science and technology, continuously revise and improve a complete quality standard system that includes TCM materials, TCM pieces, intermediates, and formulations, to ensure the quality of TCM formulations is stable and controllable.
 
Chapter 10: Drug Names and Instructions
Article 72: The naming of traditional Chinese medicine preparations should comply with the requirements of the 'Technical Guidelines for the Naming of General Names of Traditional Chinese Medicine' and relevant national regulations.
Article 73: If the TCM prescription contains toxic medicinal ingredients, or contains other TCM pieces that have been proven to be toxic by modern toxicology and may lead to serious adverse reactions, the names of the toxic TCM pieces contained in the prescription should be indicated under the [Ingredients] section of the TCM instructions, and the warning should indicate that the formulation contains these TCM pieces.
Article 74: The [Precautions] section of the instructions for new TCM drugs involving syndrome differentiation should include, but not be limited to, the following content:
(1) Situations that require caution due to factors such as TCM syndrome, pathogenesis, constitution, etc., as well as dietary and compatibility-related precautions concerning the drug;
(2) If there are post-drug care instructions, they should be clearly stated.
Article 75: The holder should strengthen the management of the entire lifecycle of the drug, enhance the monitoring, evaluation, and analysis of safety risks, and should refer to relevant technical guidelines to timely improve the TCM instructions regarding [Contraindications], [Adverse Reactions], and [Precautions].
If any item in the TCM instructions regarding [Contraindications], [Adverse Reactions], or [Precautions] remains 'unclear' three years after the implementation of these regulations, re-registration of the drug will not be granted according to the law.
Article 76: The instructions for traditional Chinese medicine compound preparations from ancient classic prescriptions should specify [Source of Prescription], [Theoretical Basis for Functions and Indications], and other items.
For new TCM drugs approved based on human experience as evidence for market approval or increased functions and indications, the instructions should include the [TCM Clinical Practice] section.
 
Chapter 11: Supplementary Provisions
Article 77: The pharmaceutical quality control of natural medicines can refer to these regulations. For innovative natural medicines in the confirmation phase of therapeutic effects, at least one phase III clinical trial data should be used to demonstrate their effectiveness. The rest should comply with the relevant requirements for new drug research on natural medicines.
Article 78: Imported TCM and natural medicines should comply with the requirements of the country or region where they are located according to drug management, and should also meet the safety, efficacy, and quality controllability requirements of domestic TCM and natural medicines. Registration application materials should be provided according to the requirements for innovative drugs. If there are other national regulations, those regulations shall prevail.
Article 79: The development of TCM and natural medicine injections should comply with the general technical requirements for injection research. The necessity and rationality of the chosen administration route should be demonstrated through sufficient non-clinical research based on the accessibility of existing treatment methods. The active ingredients and mechanisms of action should be clear, and comprehensive non-clinical efficacy and safety studies should be conducted, followed by sequential phase I, II, and III clinical trials.
After the marketing of TCM and natural medicine injections, the holder should conduct post-marketing clinical research to continuously enrich and improve evidence of clinical efficacy and safety, continuously collect adverse reaction information, timely revise and improve the instructions, and promptly conduct non-clinical safety studies for unexpected adverse reactions discovered during clinical use. The holder should strengthen quality control.
Article 80: Provincial drug supervision and management departments should submit annual reports to the national drug supervision and management department regarding the approval and filing status of TCM formulations in medical institutions. The national drug supervision and management department will include the approval and filing status of TCM formulations in medical institutions in the annual drug review report based on the reports submitted by provincial drug supervision and management departments.
Article 81: General requirements for drug registration management not covered by these regulations shall be implemented according to the 'Drug Registration Management Measures'. Separate regulations will be formulated for the registration management of TCM materials and TCM pieces subject to approval management.
Article 82: These regulations shall come into effect on July 1, 2023. The previous notice from the National Food and Drug Administration on the 'Supplementary Regulations for TCM Registration Management' (Guo Shi Yao Jian Zhu [2008] No. 3) shall be abolished simultaneously.