【正文】 rtificate (FSC) issued from the petent authorities of the local country or region where the manufacturer is located, and the GMP Certificate of the manufacturer, and the Chinese translation. Application for the drugs under Registration Category 1, the above Certified Documents can be submitted together with the clinical study report upon the pletion of the clinical study in China. However, during the application of Clinical Trails, certified documents of GMP Certificateof the manufacturer issued by local petent drug administration where the drug is manufactured must be provided. ii) When the registration of a foreign drug manufacturer is conducted by manufacturer’s office in China, copies of Registration Certificate Of Resident Office Of Foreign Enterpriseshould be provided. When a foreign drug manufacturer authorizes domestic agent to conduct the registration, copies of the authorization document, notarized document and the Chinese translation, as well as the Business License of the domestic agent shall be provided. iii) For safety experiment data, related GLP certificate should be provided, and GMP certificate should be provided for investigative drug for clinical trails. 3. Information Item 3, objectives and basis of the application, ancient and modern literature should be provided for TCM and natural drug, source of formula and basis for the application, current development of Ramp。 1 / 57 Annex 1: Registration Categories and Application Information Requirements of TCM and Natural Drugs Traditional Chinese Medicine (TCM) of thisannex refer to the medical substance and its preparation used under the guidance of Chinese traditional medical theory. Natural Drugs of this annex refer to the medical natural substance and its preparation used under the guidance of modern medical theory. Part I Registration Categories and notes I Registration Categories 1. active ingredients and its preparation extracted from plant, animal and minerals, which have not been marketed in China. 2. newly found drug material and preparations。 3. new TCM substitute 4. new part of drug material to be used as drugs, 5. new active part of material to be used as drugs and its preparation, which are extracted from plant, animal and minerals and have not been marketed in China。D in China and overseas, current clinical use and production summary, necessary analysis as for the innovation, feasibility, and rationale of dosage form, including the parison with similar drug already with National Standard, should be provided for preparation of TCM and natural drug. For TCM, traditional medical theory and ancient drug book should also be provided. 5 / 57 4. Information Item 4, summary and evaluation of main research results, includes the summary of main research results by the Applicant, and a prehensive analysis of safety, efficacy, and quality controllability of the drugs of the application. 5. Information Item 5, draft of insert sheet, notes to the draft and latest literature, includes the sample of draft of packaging insert sheet drafted in accordance with the relevant regulations, notes on how each items of the insert sheet were drafted, latest relevant literature. Summary of Pharmaceutical Study 6. Information Item 16, self test report: refer to the self test repot of sample, report for at least one batch should be provided when applying for clinical trial, upon pletion of clinical trial, self test report of 3 batch of project should be provided when submitting the dossier. Summary of pharmacology and toxicology Study 7. Information Item 24 of hypersensitive (topical, systemic and phototoxicity), hemolytic and topical irritative (blood vessel, skin, mucous membrane, and muscle) reaction, Experiments information and literature related to topical and systemic use of the drugs: Experiments information of safety of preparation should be provided according to the details of the route of administration and preparation. When there is a tendency of drug dependence, experiment data related to drug dependence should be provided. 8. information item 25: Experiments information and literature related to genotoxicity: if the formula include drug material not yet collected in statutory drug standards, or from the active part of drug material not yet collected in statutory drug standards, or new drug to be used for the child bearing patient group where it act on reproductive system (such as contraceptives, sexual hormones, drugs for sexual function disorder, drugs for maturation promoting of sperm, the new drugs with positive result in mutations test or drugs with cytotoxicity), genotoxicity test data should be provided. 9. information item 26, Experiments information and literature related to reproductive toxicity: for new drug to be used for the child bearing patient group where it may act on reproductive system (such as contraceptives, sexual hormones, drugs for sexual function disorder, drugs for maturation promoting of sperm, the new drugs with positive result in mutations test or drugs with cytotoxicity), reproductive toxicity test data should be provided according to the specific situation. 10. information item 27, Experiments information and literature related to carcinogenicity: during long term toxicity test of a new drug if cytotoxic effects were shown or extraordinary activation on the growth of cells in certain visceral ans and tissues were caused, or there is a positive test result during mutagenicity test, then experiments information and literature related to carcinogenicity must be provided. B, requirement for application dossier, 6 / 57 1. Information item 14 and 731 should usually be summated for application for clinical trails of new drug. 2. for