【正文】 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。 6. TCM, natural drugs and its bined preparation not yet marketed in China 7. preparations with change in route of administration of the TCM or natural drugs already marketed in China, 8. preparations with change in dosage form of the TCM or natural drugs already marketed in China, 9. generic drugs. II Notes Drug under category 16 refers to as new drugs, while procedure for new drugs is applicable for the new drug under category 7 and 8. 1. “active ingredients and its preparation extracted from plant, animal and minerals, which have not been marketed in China” refer to the single ponent or its preparation, which are extracted from plant, animal and minerals and not yet collected into National Drug Standards, where the content of this single ponent should be more than 90% of the extraction. 2. “newly found drug material and preparations” refer to the drug material and preparations not yet collected into National Drug Standard or provincial drug formulary (statutory standards) 3. “new TCM substitute” refer to drug material used to substitute the toxic drug material of the formula in the National Drug Standard or the endangered drug material, which is not yet collected by statutory standards. 4. “new part of drug material to be used as drugs” refer to the new part of existing drugs of animals or plants, which is to be used as drug, while the existing drugs is already in the statutory standards. 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” refer to active parts of similar or multiple ponent and its 2 / 57 preparation, which are extracted from plant, animal and minerals, and not yet collected in National Drug Standards, where the active part should be more than 50% of the extraction. 6. “TCM, natural drugs and its bined preparation not yet marketed in China” include bined preparation of TCM bined preparation of natural drugs, bined preparation of TCM, natural drugs and chemical drugs bined preparation of TCM should be formulated under traditional Chinese medical theory, including, bined preparation of TCM from ancient classic formula, bined preparation with indication of ancient term, or bined preparation with bined term. bined preparation of natural drugs should be formulated under modern medical theory, where indication should be in modern medical term. bined preparation of TCM, natural drugs and chemical drugs include bined preparation of TCM and chemical drugs, bined preparation of natural drugs and chemical drugs, and bined preparation of TCM, natural drugs and chemical drugs 7. “preparations with change in route of administration of the TCM or natural drugs already marketed in China,” refers to the preparation with transfer between route of administration or absorption location. 8. “preparations with change in dosage form of the TCM or natural drugs already marketed in China” refer to the preparation of change in dosage form but with no change in route of administration. 9. “Generic drug” refer to the registration application of TCM or natural drug already approved to be marketed in China II Application Information Items and notes A Application Information Items Summary information 1) Name of the drugs. 2) Certified Documents. 3) Objectives and basis for the application. 4) Summary and evaluation of main research results. 5) Sample draft of insert sheet, notes to the draft, and literature. 6) Sample design for packing, label. Pharmaceutical Study Information 7) Summary of Pharmaceutical Study Information. 8) Source of the drug and determination. 9) Ecological environment, identity, description, cultivation, and growing method, local processing and preparing. 10) Draft of standard of drug material, and note of drafting, with provision of drug standard material and related information. 11) Sample of plant or mineral, sample of plant include flower, fruit or seeds 3 / 57 12) Research information of production process, verification information, and literature, source of excipients and standards. 13) Experiment data and literature of chemical content study 14) Experiment data and literature of quality study 15) Draft of the drug standards, with notes to the draft and verification with provision of drug standard material and related information. 16) Test report of sample. 17) Experiment data and literature of stability study. 18) Basis for selection and quality standards of immediate packing material and container Pharmacology and Toxicology Study Information 19) Summary about the pharmacology and toxicology study information. 20) Experiments information and literature of pharmacodynamic. 21) Experiments information and literature of regular pharmacology study.