Chinese Medicine Registration supplementary provisions 
  
  


  

  
  

    The first to reflect the characteristics of Chinese medicine, Chinese medicine research to follow rules, inherited traditions, encourage innovation, support the promotion of Chinese medicine and the development of national pharmaceutical industry, according to "Drug Registration", the enactment of this supplementary provisions.
    The second development of new drugs Yingdang Chinese medicine theory in line with, pay attention to the basis of clinical practice, with clinical value, to ensure the safety of traditional Chinese medicine effective and uniform quality, protection of traditional Chinese medicine Laiyuan stability and sustainable use of resources and should focus on the environment protection factors. Involving endangered wildlife shall comply with relevant regulations.
    Article III is not the main medical treatment card medicine approved by the state 【Indication】 contained in the collection of new drugs, a "Drug Registration Regulation," the forty-fifth, paragraph (d) of the range.
    Fourth application for registration of Chinese medicine, prescription form should be clear, the base of the original herbs, medicinal herbs origin and resources as well as pre-treatment (including processing), extraction, separation, purification, formulation and other processes, identify key process parameters.
    Article in traditional Chinese medicine should be guided by the theory of Chinese medicine prescriptions, the prescription consists of Chinese Herbal Medicine (medicine), extract the effective part and effective ingredients.
With no statutory standards, such as herbs, should be separately established quality standards; not a valid part of the standard and active ingredients, quality standards should be established separately and in accordance with the appropriate registration category provides research information; herbal extracts should establish quality control standard, with quality standards in the preparation after.
    Article Summary of traditional Chinese medicine In addition to providing information, pharmaceutical research data, shall be in accordance with the provisions of Article VII, VIII and IX, the requirements of different types to provide relevant information on pharmacology and toxicology and clinical trials.
    Article from the side of the ancient classics of Chinese medicine compound, is still widely used and effective, with significant features and advantages of the Qing Dynasty and the Qing Dynasty before the prescriptions recorded in medical books.
(A) the specific type of traditional Chinese medicine directory by the State Food and Drug Administration to assist relevant departments to develop and publish.
(B) meet the following conditions of such traditional Chinese medicine, can only provide information on non-clinical safety studies, and reporting directly to the production:
1. Prescription medicines or non-toxic incompatibility;
2. Smell has the statutory standard prescription;
3. Production process is consistent with the traditional process;
4. Route of administration consistent with the records of ancient medical books, the daily volume Pieces of ancient medical books and records fairly;
5. Indications consistent with the records of ancient medical books;
6. Scope does not include critical illness, do not involve pregnant women, infants and other special treatment groups.
(C) the class of medicines traditional Chinese medicine prescription and instructions must state the specific source of Indications, indicating long-term clinical application of this basic recipe, and by the non-clinical safety evaluation.
(D) the class is not given the traditional Chinese medicine drug certificate.
    Article VIII syndrome attending the traditional Chinese medicine, Chinese medicine refers to the theoretical guidance for the treatment of syndromes of traditional Chinese medicine, including medical treatment of disease or symptoms of traditional Chinese medicine.
(A) of the class composition of traditional Chinese medicine prescription medicine should be in line with the theory and clinical application of certain basic and function expression of TCM terms shall be attending.
(B) the prescription of such sources of traditional Chinese medicine, the reasonable set of clinical applications, functions, usage amount and so by the State Food and Drug Administration Center for Drug Evaluation Organization of Chinese medicine expert review.
(C) Evaluation should be based syndromes. Validation syndromes in clinical trials can take a variety of design methods, but should fully explain the science, the number of cases should meet the requirements of biostatistics, clinical trial results should be biologically significant.
(D) have sufficient clinical data to support, and the production process, usage, dosage and consistent with previous clinical applications, and may only provide information on non-clinical safety trials; clinical research can be directly Ⅲ clinical trials.
(E) production process, usage, dosage is inconsistent with previous clinical applications, and should provide non-clinical safety and efficacy study of test data information. Pharmacodynamic Study of TCM should be used animal model; such as lack of mature Syndrome animal model, to encourage drug-related Indications Pharmacodynamic tests. Clinical research should be conducted Ⅱ, Ⅲ clinical trial.
(F) the class of drugs manual traditional Chinese medicine clinical trials】 【describe the items focus on the efficacy of TCM, and that the related impact of the disease.
    Article IX Syndrome Indications for the combination of traditional Chinese medicine in the "disease" refers to a disease of modern medicine, "card" refers to syndromes of Chinese medicine, the function expressed by Chinese technical terms, treating diseases of modern medicine and traditional Chinese medicine syndrome a combination formulation.
(A) Gailei traditional Chinese medicine compound preparation Chufang Zuchengyingdang meet Chinese medicine theory, and have some basis for clinical application.
(B) has sufficient information to support clinical applications, and the production process, usage, dosage consistent with previous clinical applications, and may only provide information on non-clinical safety trials; clinical research should be conducted Ⅱ, Ⅲ clinical trial.
(C) of the production process, usage, dosage and clinical application of previous inconsistent, should provide information on non-clinical safety trials, and with the proposed Indication (indications) for the main pharmacodynamic test. Pharmacodynamic study should generally be used TCM animal model or disease model; such as lack of mature Syndrome or disease model animal models, can be and function (pharmacological effects) related to the main pharmacodynamic test. Clinical research should be conducted Ⅱ, Ⅲ clinical trial.
     Article on changing the dosage listed medicines but does not change the route of application for registration should provide a sufficient basis on its scientific rationality. New technologies should be used to improve the quality and safety of drugs, and compared with the original formulation has obvious clinical advantages.
(A) if the base of the original ingredients, production process (including pre-medicine, extraction, separation, purification, etc.) and process parameters, such as changes in prescription formulations, little change in the basis of pharmaceutical substances, dosage form change of the absorption of drugs small, pharmacology and toxicology studies may be required to provide information, and the number of cases should be not less than 100 pairs of clinical trials for multiple disease and syndrome, and every major at least 60 the number of cases of disease and syndrome right.
(B) if the base of the original ingredients, production process (including pre-medicine, extraction, separation, purification, etc.) and process parameters, prescriptions and other agents have a greater change in the basis of changes in the larger pharmaceutical substances, or the absorption of the drug formulation change the use of large, should provide relevant pharmacology and toxicology research and Ⅱ, Ⅲ clinical trial data.
(C) slow and controlled release formulations should be based on normal preparations of human pharmacokinetic parameters and clinical practice need to establish title as the basis of preclinical studies should include sustained release, controlled release formulations and their general preparation in medicine, biology Comparison of experimental data, clinical research, including human pharmacokinetics and clinical efficacy and safety study of comparative test data to demonstrate the release of such agents of special features and advantages.
    Article XI application for registration of generic drugs, should be composed of generic prescription drugs, herbal medicine base of the original, the production process (including pre-medicine, extraction, separation, purification, etc.) and process parameters, consistent prescription preparation, quality control of be not less than generic drugs. If you can not determine the specific process parameters, such as preparation and being generic prescription drugs consistent, comparative study should be conducted to ensure the quality and consistency of generic drugs has been, and the number of cases less than 100 pairs of clinical trials or bioequivalence study.
    Article XII of prescription drugs has changed the materials required supplementary medicinal applications, such as non-toxic prescription medicines, supplies, changes in the absorption of drugs, the use of no significant impact, not cause safety and effectiveness of significant change, you can not provide information on pharmacology and toxicology testing and clinical trial data; such as changes in the materials the absorption of the drug use may have significant effect on the pharmacology and toxicology tests should provide information and Ⅱ, Ⅲ clinical trial data.
    Article XIII changed the production process of pharmaceutical quality supplement applications, such as prescription medicine non-toxic, does not cause changes in the production process the material basis of the change in the absorption of drugs, the use of no significant impact, will not cause safety and effectiveness of significant change, you can not provide information on pharmacology and toxicology testing and clinical trial data; such as changes in the production process the material basis of its impact, but little change in the absorption of drugs, the use of no significant impact, may pharmacology and toxicology tests to provide information on the number of cases less than 100 pairs of clinical trials for multiple disease and syndrome, and each of the major number of cases of disease and syndrome of not less than 60 pairs; such as changes in production processes will cause the material basis change significantly, or the absorption of drugs, the use may have significant effect on the pharmacology and toxicology tests should provide information and Ⅱ, Ⅲ clinical trial data.
    Article XIV of the changes to be carried out pharmacological studies have been listed pharmaceutical dosage form, change the production process and changing the route of application for registration should be based on the original formulation, the original production process or the original route of administration for pharmacodynamic trials for the control (control can only established a high-dose group).
    Article XV of the effective parts of the new applications for registration of agents, such as single herb preparations have been listed and Indications (indication) is consistent with the single herb preparation should be carried out non-clinical and clinical comparative study to demonstrate its advantages and characteristics of .
    Article XVI of the non-clinical safety testing of samples should be used in the above test or pilot-scale samples. Clinical trial samples should normally be used in the production scale of the sample; for the active ingredients or preparation made parts, can be above the pilot or pilot-scale samples.
    Article XVII prescription medicines or toxic materials not of the standard, or non-clinical safety trials resulted in a significant clinical toxicity and other safety concerns, an application for registration of Chinese medicine, clinical trials should be conducted Ⅰ. Article XVIII new drug application for registration, the applicant may apply depending on the circumstances stages (Ⅰ, Ⅱ, period, Ⅲ period) clinical trials, and phase clinical trials support the appropriate course of non-clinical safety testing data.
Clinical trial stage is complete, the application can apply to add the next phase of clinical trials.
    According to Article XIX of clinical trials need to test purposes, scientific rationality, feasibility and other criteria to select the control drug. The choice of placebo should be consistent with ethical requirements, the positive control drug selection should be sufficient clinical evidence. Pharmaceutical dosage forms have been listed on the change, change the production process, has been listed in the prescription drugs on the basis of addition and subtraction of the CD and features traditional Chinese medicine preparation attending basically the same, need to select the listed drugs as a positive control drug.
    Diershitiao during clinical trials, according to research conditions and specifications preparation process can be adjusted, if adjusted for effectiveness and safety may be affected and should be reported to supplement the application form and provide relevant research information.
    Article a Tibetan, Uighur Medicine, Mongolian and other ethnic medicines with reference to the provisions of the Registry. Development should be consistent with national medicine national medical theory, the application production enterprises should have the appropriate national medicine professionals, production conditions and capabilities, and its review should be organized drug-related aspects of national experts.
    Twenty-two of the provisions come into force from the date of publication.