Special Provisions on the Registration and Management of Chinese Medicines

Chapter I General Provisions

Article 1 In order to promote the development of traditional Chinese medicine inheritance and innovation, follow the laws of traditional Chinese medicine research, and strengthen the management of the development and registration of new traditional Chinese medicine, according to the "Chinese People's Republic of China *** and the State Drug Administration Law" "Chinese People's Republic of China *** and the State Law on Traditional Chinese Medicine" "Chinese People's Republic of China *** and the State Regulations for the Implementation of the Drug Administration Law" "Regulations on the Administration of Drug Registration," etc., laws, statutes, regulations and rules are formulated.

Second, the development of new Chinese medicine shall focus on reflecting the original thinking and holistic view of Chinese medicine, and encourage the use of traditional Chinese medicine research methods and modern science and technology research and development of Chinese medicine. It supports the development of new Chinese medicines based on ancient classical prescriptions, experienced prescriptions of famous Chinese medicine practitioners, and Chinese medicinal preparations prepared by medical institutions (hereinafter referred to as Chinese medicinal preparations of medical institutions) and other new Chinese medicines with rich experience of Chinese medicine clinical practice; it supports the development of new Chinese medicines that have the function of systematic regulation and intervention of the human body; and it encourages the application of emerging sciences and technologies to study and explain the mechanism of action of Chinese medicines.

Article 3 The development of new Chinese medicines shall be oriented to clinical value, emphasize clinical benefit and risk assessment, give full play to the unique advantages and functions of Chinese medicine in preventing and treating diseases, and focus on meeting unmet clinical needs.

Article 4 The development of new Chinese medicines shall be in accordance with the theory of Chinese medicine, and the formulation shall be rationalized under the guidance of the theory of Chinese medicine, and the functions, treatments, applicable population, dosage, duration of treatment, efficacy characteristics and contraindications of taking medicines shall be formulated. Encourage the observation of disease progression, transformation of symptoms, changes in symptoms, post-drug reactions and other patterns in the clinical practice of Chinese medicine, and provide evidence of the support of Chinese medicine theory for the development of new Chinese medicines.

Article V. New Chinese medicines derived from the clinical practice of traditional Chinese medicine shall, on the basis of summarizing the experience of individual use of medicines, gradually clarify the functions and treatments, applicable to the population, the administration of the program and the clinical benefits, and the formation of a fixed prescription, and on the basis of the development of new Chinese medicines suitable for the group use of medicines. Encourage

To carry out high-quality empirical research on human use in the course of clinical practice of Chinese medicine, to clarify the clinical positioning and clinical value of Chinese medicines, and to analyze and summarize them continuously based on scientific methods, so as to obtain sufficient evidence to support registration.

Article 6: The review of Chinese medicine registration shall adopt the review evidence system combining the theory of Chinese medicine, human experience and clinical trials, and comprehensively evaluate the safety, efficacy and quality controllability of Chinese medicines.

Article 7 The evaluation of the efficacy of traditional Chinese medicine shall be combined with the clinical and therapeutic characteristics of traditional Chinese medicine, to determine the efficacy of the end of the indicators appropriate to the clinical positioning of traditional Chinese medicine, reflecting the characteristics and advantages of its role. Evaluations of cases such as curing or delaying the development of a disease, improving the condition or symptoms, improving the patient's body function or quality of life in relation to the disease, increasing the effectiveness and reducing the toxicity in combination with chemical drugs or reducing the dosage of chemical drugs that have obvious toxic side effects, etc., can be used to evaluate the therapeutic efficacy of traditional Chinese medicines.

The use of real-world studies, novel biomarkers, alternative endpoint decision-making, patient-centered drug development, adaptive design, and enrichment design for the evaluation of the efficacy of traditional Chinese medicines is encouraged.

Article 8 The safety and benefit-risk ratio of traditional Chinese medicines shall be comprehensively evaluated based on the composition and characteristics of prescriptions, theories of traditional Chinese medicine, human experience, clinical trials and the results of necessary non-clinical safety studies, so as to strengthen the management of traditional Chinese medicines throughout their life cycle.

Article 9 The applicant for registration (hereinafter referred to as the applicant) shall strengthen the quality control of the source of Chinese herbal medicines and Chinese herbal medicines, carry out the assessment of the resources of the medicinal materials, ensure that the source of the medicinal materials can be traced, and make clear the base of the medicinal materials, the place of origin, and the period of harvesting, etc. The applicant shall strengthen the quality control of the whole production process. Strengthen the quality control of the whole production process, and maintain stable and controllable quality between batches. Chinese medicine prescription flavors can be cast after quality homogenization.

Article 10 The applicant shall guarantee the sustainable utilization of the resources of Chinese herbal medicines, and shall pay attention to the impact on the ecological environment. Involving endangered wildlife and plants, shall comply with the relevant state regulations.

Chapter II Classification and Listing Approval of Chinese Medicines

Article 11 The classification of Chinese medicines for registration includes innovative medicines of traditional Chinese medicine, improved new medicines of traditional Chinese medicine, compound preparations of traditional Chinese medicines with ancient classical prescriptions, and medicines with the same name and the same formula. The specific circumstances of the registration classification of Chinese medicines and the corresponding declaration information requirements shall be implemented in accordance with the relevant provisions of the registration classification of Chinese medicines and the declaration information requirements.

Article 12 The research and development of new Chinese medicines shall be combined with the registration classification of Chinese medicines, and the research and development path or mode that meets the characteristics of the varieties shall be selected according to the varieties. Chinese medicines based on theories of traditional Chinese medicine and human experience in discovering and exploring the characteristics of therapeutic efficacy shall mainly confirm their therapeutic efficacy through human experience and/or necessary clinical trials; Chinese medicines to be developed based on pharmacological screening studies shall conduct necessary phase I clinical trials and carry out phase II clinical trials and phase III clinical trials in a sequential manner.

Article XIII The application for listing of compound preparations of traditional Chinese medicines with ancient classical prescriptions shall be subject to simplified registration and approval, and the specific requirements shall be implemented in accordance with the relevant provisions.

Article 14 Priority review and approval shall be given to the registration applications of new Chinese medicines with clear clinical positioning and obvious clinical value in the following cases:

(1) for the prevention and treatment of major diseases, new and outbreaks of infectious diseases, and rare diseases;

(2) in urgent clinical need and in short supply in the market;

(3) for the use of children;

(4) newly discovered (d) newly discovered medicinal materials and their preparations, or new medicinal parts of medicinal materials and their preparations;

(e) the basis of medicinal substances is clear, and the mechanism of action is basically clear.

Article 15 For the treatment of serious life-threatening diseases for which there is no effective treatment, as well as the State Council department in charge of health or traditional Chinese medicine to determine the urgent need for traditional Chinese medicines, clinical trials of the drug data or high-quality traditional Chinese medicines with empirical evidence showing the efficacy of human use and can predict the clinical value of the drug, can be approved conditionally, and the drug certificate of registration in the relevant matters set out.

Article 16 In the event of a public **** health emergency, the State Council health or Chinese medicine department in charge of determining the urgent need for traditional Chinese medicine, can be applied to human empirical evidence directly in accordance with the special approval procedures to apply to carry out clinical trials or marketing authorization or to increase the function of the main treatment.

Chapter III: Reasonable Application of Evidence of Human Experience

Article 17 The human experience of Chinese medicines is usually accumulated in clinical practice, with certain regularity, repeatability and clinical value, and includes the knowledge and summary of clinical positioning, applicable population, dosage, efficacy characteristics and clinical benefits of the prescription or preparation of Chinese medicines that have been accumulated during clinical use of medicines.

Article 18 The applicant may collect and organize human experience in multiple ways, and shall be responsible for the authenticity and traceability of the information, and the standardized collection, organization and evaluation of human experience shall comply with the relevant requirements. As the key evidence to support the registration application of human experience data, the drug supervision and management department in accordance with the relevant procedures to organize and carry out the appropriate verification of drug registration.

Article 19 of the data for reasonable and adequate analysis and give the correct interpretation of the results of the human experience can be used as evidence to support the registration application. The applicant may, according to the degree of support for the safety and efficacy of the drug by the existing evidence of human experience, determine the follow-up research strategy, and provide the appropriate reporting information.

Article 20 As the key evidence to support the application for registration of human experience in the use of drugs used in the prescription flavor (including the original, medicinal parts, concoctions, etc.) and its dose should be fixed. The pharmacological key information and quality of the declared preparations shall be basically consistent with the drugs used in human experience, and if there are changes in the preparation process, excipients, etc., they shall be evaluated and provided with research and evaluation information to support the relevant changes.

Article 21 The prescription of innovative Chinese medicine is derived from ancient classical prescriptions or traditional Chinese medicine clinical experience, such as the composition of the prescription, clinical positioning, dosage, etc. and previous clinical applications are basically the same, the use of traditional processes that are basically the same as those of the clinically used drugs, and can be initially determined through human experience of the main functions, the applicable population, the drug delivery program and the clinical benefits, etc., may not carry out non-clinical validity studies. The study may not carry out non-clinical effectiveness research.

Article 22 The compound preparations of traditional Chinese medicines composed of Chinese medicinal herbs shall generally provide information on toxicity test of single administration to rodents and toxicity test of repeated administrations, and if necessary, provide information on other toxicological tests.

If the prescription of a compound preparation of traditional Chinese medicine is composed of Chinese medicinal herbs that have national drug standards or have drug registration standards, the prescription does not contain toxic flavors or does not contain Chinese medicinal herbs that have been proved by modern toxicology to be toxic and prone to cause serious adverse reactions, adopts the traditional technology, is not used for special groups such as pregnant women and children, and the toxicity test for a single administration of the drug and the toxicity test for a repeated administration of the drug to an animal have not found obvious toxicity, the toxicity test for a single administration of the drug and the toxicity test for a repeated administration of the drug to an animal have not found obvious toxicity. Administration toxicity test did not find obvious toxicity, generally do not need to provide another animal repeated administration toxicity test, as well as safety pharmacology, genotoxicity, carcinogenicity, reproductive toxicity and other test information.

The toxic medicinal flavors referred to in this provision refers to the toxic Chinese medicine varieties included in the "Measures for the Administration of Toxic Drugs for Medical Purposes".

Article 23 New Chinese medicines derived from clinical practice, human experience can provide research and supporting evidence in clinical positioning, screening of applicable populations, therapeutic exploration, dosage exploration, etc., may not carry out phase II clinical trials.

Article 24 The clinical research and development of Chinese medicines with human experience, on the basis of prescription, production process fixation, the existence of applicable high-quality real-world data, and through well-designed clinical research to form the real-world evidence of scientific adequacy, the applicant on the real-world research program and the national drug evaluation agency to communicate and reach an agreement, the applicant may apply for real-world evidence as one of the bases of support for product marketing. One of the basis for marketing.

Article 25 The medical institutions are responsible for the safety, effectiveness and quality control of the Chinese medicinal preparations in the medical institutions, and shall continue to standardize the collection and collation of the information on the experience of the Chinese medicinal preparations in the medical institutions, and submit a report on the collection and collation of the experience of the Chinese medicinal preparations in the medical institutions and the assessment of the experience of the Chinese medicinal preparations in the medical institutions to the provincial drug supervision and management authorities at the location on a yearly basis.

Article 26 The new Chinese medicines originating from the preparations of medical institutions, such as prescription composition, process route, clinical positioning, dosage, etc. and the previous clinical application of basic consistency, and can be initially determined through the experience of human use of the function of the primary treatment, the applicable population, the administration program and the clinical benefits, etc., may not carry out non-

clinical effectiveness research. If the composition of the prescription, extraction process, dosage form, direct contact with the packaging of the drug is consistent with that of the Chinese medicine preparation in the medical institution, based on the provision of information on the pharmacological study of the Chinese medicine preparation in the medical institution, it may not provide information on the choice of dosage form, screening of the process route, and study of packaging materials in direct contact with the drug.

Article 27 The applicant may, according to the specific varieties, in the key research and development stage for the theory of traditional Chinese medicine, human experience research programs and human experience data, etc., to communicate with the national drug evaluation agencies.

Chapter IV Innovative Medicines of Traditional Chinese Medicine

Article 28 Innovative medicines of traditional Chinese medicine shall have sufficient evidence of efficacy and safety, and in principle shall be subject to randomized controlled clinical trials prior to marketing.

Article 29 Encouragement of clinical trials and efficacy evaluation of innovative Chinese medicines based on the clinical practice of traditional Chinese medicine, exploring the use of sequential combination of medicines based on clinical treatment programs.

Article 30 Encourages clinical trials of innovative medicines of traditional Chinese medicine to prioritize the use of placebo control, or placebo control loaded with basic treatment, when ethical requirements are met.

Article 31 Drinking tablets and extracts of traditional Chinese medicines may be used as prescription components of compound preparations of traditional Chinese medicines. If Chinese herbal medicinal tablets and extracts containing no national drug standards and not having drug registration standards, their drug standards shall be attached to the drug standards of the preparations.

Article 32 The extracts and their preparations should have sufficient basis for the topic, to carry out effectiveness, safety and quality control studies. Should be studied to determine the reasonable preparation process. Should be studied to clarify the structure of the major components contained in the type of structure and the structure of the main components, through the establishment of the main components, the content of the major components and fingerprints or characteristics of the mapping and other quality control projects, fully characterized extracts and preparations, to ensure that the quality of different batches of extracts and preparations are uniform and stable.

Article 33 The application for registration of new extracts and their preparations, such as single-flavored preparations or single-flavored extract preparations on the market and the basic function of the same (indications), should be non-clinical and clinical comparative studies with such preparations to illustrate the advantages and characteristics.

Article 34 The application for registration of new medicinal materials and their preparations shall provide information on the research on the nature, flavor, attribution and efficacy of the medicinal materials, and the relevant research shall provide supporting evidence for the nature, flavor, attribution and efficacy of the new medicinal materials.

Article 35 Chinese medicine compound preparations can be classified into different cases according to their main treatments:

(1) Chinese medicine compound preparations whose main treatment is the evidence of a disease or symptom of traditional Chinese medicine are those used for the treatment of the evidence of traditional Chinese medicine under the guidance of the theory of traditional Chinese medicine, including those used for the treatment of the disease or symptom of traditional Chinese medicine, and their functional treatments shall be expressed in the terminology of traditional Chinese medicine;

(B) the main treatment for the combination of disease and evidence of Chinese medicine compound preparations, the "disease" refers to modern medical diseases, "evidence" refers to the evidence of Chinese medicine, the function of which is expressed in the terminology of Chinese medicine, the main treatment of the combination of modern medical diseases and Chinese medicine evidence expressed in the way;

(c) the main treatment for the disease of Chinese medicine compound preparations, belonging to the disease-specific medicines, in the theory of Chinese medicine under the guidance of the formula. The "disease" involved is a modern medical disease, the function of which is expressed in Chinese medical terminology, and the main treatment is expressed as a modern medical disease.

Article 36 The applicant for registration of an innovative Chinese medicine may, in accordance with the characteristics of the Chinese medicine and the general rules of new drug development, carry out a phased study for the main purpose of the different stages of the study, such as applying for a clinical trial, pre-Phase III clinical trial, and applying for a marketing authorization. The phased study of Chinese medicine pharmacy should reflect the quality from the design concept, focusing on the holistic and systematic nature of the study.

Article 37 Innovative Chinese medicine shall be based on the composition of prescription medicines, medicinal taste and medicinal properties, drawing on the experience of using medicines to meet the clinical needs for the purpose of a comprehensive analysis of the production process, physical and chemical properties of the drug, the traditional way of using medicines, biological properties, dosage form features, the safety of clinical use of medicines, patients' adherence to medication and other aspects of a reasonable choice of dosage forms and routes of drug delivery. If you can choose to take the drug orally, do not choose to inject the drug.

Article 38 The development of innovative Chinese medicine shall be based on the characteristics of the drug, clinical application and other safety information obtained, to carry out the corresponding non-clinical safety tests. The corresponding non-clinical safety tests may be carried out according to different registration classifications, risk assessments, and development processes.

Article 39 The samples used in the non-clinical safety tests, should be used in pilot or pilot scale samples. Declaration of clinical trials, should provide information on the preparation of samples for non-clinical safety tests. Drugs for clinical trials shall generally use production-scale samples. When declared for marketing, information should be provided on the preparation of drugs for clinical trials, including test drugs and placebos.

Article 40 The following circumstances, the necessary phase I clinical trials shall be carried out:

(1) prescription containing toxic flavors;

(2) in addition to prescriptions containing Chinese herbal medicinal herbs that have a history of practice and have been included in the provincial standard of Chinese herbal medicinal concoctions, prescriptions containing Chinese herbal medicinal herbs and extracts without national drug standards and do not have the standard of registration of medicines;

(3) non Clinical safety test results show obvious toxic reactions and suggest that the human body may have certain safety risks;

(d) the need to obtain human pharmacokinetic data to guide clinical use of medicines and other applications for registration of traditional Chinese medicines.

Chapter V: Improved New Medicines of Traditional Chinese Medicine

Article 41 supports the holders of marketing licenses for medicines (hereinafter referred to as the holders) to carry out research on improved new medicines. The research and development of improved new medicines shall follow the principles of necessity, scientificity and reasonableness, and the purpose of improvement shall be clearly defined. On the basis of marketed drugs, based on an objective, scientific and comprehensive understanding of the improved drugs, research shall be conducted on the deficiencies of the improved traditional Chinese medicines or newly discovered therapeutic features and potentials in the process of clinical application. The research and development of improved new medicines for children should be in line with the growth and development characteristics of children and their medication habits.

Article 42 The improved new drugs that change the dosage form or route of administration of marketed traditional Chinese medicines shall have the advantages and characteristics of clinical application, such as increasing effectiveness, improving safety, and improving compliance, etc., or, on the premise that effectiveness and safety will not be reduced, to promote environmental protection, and to enhance the level of production safety.

Article 43 The application for registration of a change in the route of administration of a listed drug shall state the reasonableness and necessity of the change in the route of administration, carry out the corresponding non-clinical studies, and carry out clinical trials around the purpose of the modification, and prove that the change in the route of administration of the clinical application of the advantages and characteristics.

Article 44 The application for registration of a change in the dosage form of listed traditional Chinese medicine shall be combined with the clinical therapeutic needs, the physical and chemical properties of the drug and biological properties, etc. to provide sufficient evidence of its scientific rationality. The applicant shall carry out appropriate pharmacological research according to the specific circumstances of the new dosage form and, if necessary, carry out non-clinical effectiveness, safety research and clinical trials.

For children's drugs, special populations (such as dysphagia, etc.), some special use of listed Chinese medicines and inconvenient to use, by changing the dosage form to improve the clinical use of the drug compliance, if comparative studies show that after the change of the dosage form of the medicinal material basis and drug absorption, utilization, and the original dosage form of clinical value based on sufficient evidence, may not carry out clinical trials.

Article 45 For Chinese medicines to increase their functions, in addition to the cases stipulated in Articles 23 and 46, non-clinical validity studies shall be provided, and phase II and phase III clinical trials shall be carried out in a sequential manner.

In the case of prolonging the medication cycle or increasing the dosage, non-clinical safety research data shall be provided. If relevant non-clinical safety studies have been conducted prior to marketing and can support the extension of the cycle or increase the dose, new non-clinical safety tests may not be conducted.

If the applicant does not hold a listed Chinese medicine and applies for an increase in the function of the main treatment, the applicant should also submit an application for the registration of the same name and the same formula of the same medicine.

Article 46 Where a listed Chinese medicine applies for the addition of a functional mainstay, and its empirical evidence of human use supports the corresponding clinical position, it may not provide information on non-clinical effectiveness tests. If the dosage and duration of treatment do not increase, and the applicable population remains unchanged, non-clinical safety test information may not be provided.

Article 47 encourages the use of new technologies and processes suitable for the characteristics of the product to improve listed Chinese medicines. Listed Chinese medicine production process or auxiliary materials and other changes caused by the medicinal material base or drug absorption, utilization of obvious changes, should be to improve the effectiveness or improve the safety of research purposes, to carry out the relevant non-clinical effectiveness, safety testing and phase II clinical trials, phase III clinical trials, in accordance with the improved new drug registration declaration.

Chapter VI: Compound Preparations of Ancient Classical Prescriptions of Traditional Chinese Medicines

Article 48 The compound preparations of ancient classical prescriptions of traditional Chinese medicines that do not contain contraindications for compound preparations of traditional Chinese medicines, or medicines labeled as highly toxic, highly toxic, or toxic as proved by modern toxicology, shall be prepared by traditional techniques, with traditional routes of administration, and with the functions and treatments expressed in traditional Chinese medicine terminology. The development of such Chinese medicine compound preparations does not require non-clinical effectiveness studies and clinical trials. Drug approval numbers are given in a specialized format.

Article 49 The ancient classic prescription Chinese medicine compound preparation adopts the review mode based on expert opinion. The expert review committee of ancient classic prescriptions of Chinese medicine compound preparations mainly composed of national medical masters, academicians and national famous Chinese medicine practitioners shall conduct technical review of such preparations and issue technical review opinions on whether to agree to be marketed or not.

Article 50: For the application for listing of Chinese medicine compound preparations managed in accordance with the catalog of ancient classical prescriptions, the applicant shall carry out the corresponding pharmacological research and non-clinical safety studies. In principle, the composition of the prescription, the base material, the medicinal parts, the preparation specifications, the converted dosage, the dosage, the function and the principal treatment, etc. shall be consistent with the key information of the ancient classical prescriptions issued by the State.

Article 51 The application for registration of other traditional Chinese medicine compound preparations derived from ancient classical prescriptions shall, in addition to providing the corresponding pharmacological research and non-clinical safety test data, provide the key information of the ancient classical prescriptions and their bases, and shall provide a systematic summary of the clinical practice of Chinese medicine, indicating its clinical value. The addition, subtraction and customization of ancient classic prescriptions should be carried out under the guidance of Chinese medicine theory.

Article 52 encourages the applicant, based on the characteristics of the ancient classic prescription Chinese medicine compound preparation, in the key stage of research and development, on the baseline sample research, non-clinical safety research, the standardized collection and arrangement of human experience and summary of clinical practice of traditional Chinese medicine and other major issues to communicate with the national drug evaluation agency.

Article 53 After the listing of ancient classical Chinese medicine compound preparations, the holder shall carry out post-marketing clinical research, and constantly enrich and improve the clinical effectiveness and safety evidence. The holder shall continuously collect information on adverse reactions, promptly revise and improve the specification, and carry out timely non-clinical safety studies on unanticipated adverse reactions found in the course of clinical use.

Chapter VII Homonym Drugs

Article 54 The development of homonym drugs shall avoid low-level duplication. The applicant shall evaluate the clinical value of the marketed traditional Chinese medicine (hereinafter referred to as the control homonym drug) which is used for control and has the same name and formula as the drug under development. The safety, efficacy and quality control of the homonym drug applied for registration shall be no less than that of the control homonym drug.

Article 55 The development of homonymous medicines of the same name shall be compared with the control of homonymous medicines of the same name in terms of quality control of the whole process of Chinese herbal medicines, Chinese herbal medicines, intermediates, preparations, etc. The applicant shall apply for registration of homonymous medicines of the same name based on the quality control of the whole process of Chinese herbal medicines. The applicant shall evaluate whether to carry out non-clinical safety studies and clinical trials based on the evidence of the effectiveness and safety of the controlled homonymized drug, as well as the results of the comparison of the homonymized drug with the controlled homonymized drug in terms of process and excipients.

Article 56 The applicant shall select the control homonymous drug based on the results of clinical value assessment. The control of the same name and the same formula should have sufficient evidence of effectiveness and safety, in accordance with the requirements of drug registration and management to carry out clinical trials of Chinese medicines approved for marketing, the current version of the Chinese People's *** and the State Pharmacopoeia of the listed Chinese medicines, as well as listed Chinese medicines have received the certificate of protection of varieties of traditional Chinese medicines, can generally be regarded as having sufficient evidence of effectiveness and safety.

The listed Chinese medicines which have obtained the certificate of protection of Chinese medicines referred to in the preceding paragraph refer to the protected varieties of Chinese medicines which have ended their protection period, as well as other protected varieties of Chinese medicines in compliance with the relevant provisions of the Chinese medicine variety protection system.

Article 57 Where a homonymous homoeopathic medicine applying for registration needs to be compared with a control homonymous homoeopathic medicine by means of clinical trials, at least phase III clinical trials shall be conducted. Extracted single-ingredient traditional Chinese medicines may prove their consistency with the control homonymous homoeopathic medicines through bioequivalence tests.

Article 58 The varieties which have national drug standards without drug approval numbers shall apply for registration in accordance with the same name and the same formula. The applicant shall, in accordance with its theory of Chinese medicine and human experience, conduct the necessary clinical trials.

Article 59 There is sufficient evidence of the effectiveness and safety of the control homonymous homoeopathic medicine, the homonymous homoeopathic medicine of the same process, excipients and the control of the same homonymous homoeopathic medicine, or homonymous homoeopathic medicine of the process, excipients changes in the research and evaluation does not cause medicinal material basis or drug absorption, utilization of significant changes, generally do not need to carry out non-clinical safety studies and clinical trials.

Chapter VIII Post-market Changes

Article 60 Changes in listed traditional Chinese medicines shall be made in accordance with the characteristics and laws of traditional Chinese medicines, and in line with the relevant requirements of necessity, scientificity and reasonableness. The holder shall fulfill the main responsibility of change research, assessment and change management, and comprehensively assess and verify the impact of the change on the safety, efficacy

and quality controllability of the medicines. According to the research, assessment and related verification results, to determine the listed Chinese medicine change management category, the implementation of changes should be approved in accordance with the provisions of the record or report. Holders can carry out timely communication with the corresponding drug supervision and management authorities in the process of post-marketing change studies.