【正文】 Denote literature can be used instead of test information, or may be exempted by regulation, 10 / 57 3. ?Denote the information may be exempted, 4. ▲Denote the information may not be provided for those TCM of natural drug listed in statutory standards, and if not listed, data must be submitted. 5. * Denote the information shall be submitted according to the requirement 11 / 57 Annex 2: Registration Categories and Application Information Requirements of Chemical Drugs I Registration Categories 1) New chemical entity never marketed in any country. i. Drug substance and its preparations made by synthesis or semisynthesis. ii. Chemical monomer (including drug substance and preparation) extracted from natural sources or by fermentation. iii. Optical isomer (including drug substance and preparation) obtained by chiral separation or synthesis. iv. Drug with fewer ponents derived from marketed multiponent drug. v. New bination products. vi. A preparation already marketed in China but with a newly added indication not yet approved in any country. 2) Drug preparation with changed administration route and not marketed in any country 3) Drug marketed exChina, including: i. Drug substance and its preparations, and / or with changed dose form, but no change of administration route. ii. Combination preparations, and / or with changed dose form, but no change of administration route. iii. Preparations with changed administration route and marketed exChina. iv. A preparation already marketed in China but with a newly added indication approved exChina. 4) Drug substance and its preparation with changed acid or alkaline radicals (or metallic elements), but without any pharmacological change, and the original drug entity already approved in China. 5) Drug preparation with changed dose form, but no change of administration route, and the original preparation already approved in China, 6) Drug substance or preparation following national standard. II Application Dossier Items A Summary 1) Name of the drugs. 2) Certified Documents. 3) Objectives and basis for R amp。 + + – – – 22 + + * + + + + + + 177。 – 15 + + + + + + + + + + + 16 + + + + + + + + + + + 17 + + + + + + + + + + + 18 + + + + + + + + + + + Pharmacology and toxicology 19 + + * + + + + + + 177。 + + + 177。 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