【正文】 D. 4) Summary of main study work. 5) Draft of packaging insert, note to the draft, and latest literature. 6) Design of packaging and labeling. B Pharmaceutical data 7) Summary of Pharmaceutical Study, 8) Research information and relevant literature of the production process of the drug substance, research information and relevant literature of formula and process of the preparations. 12 / 57 9) Study information and relevant literature for the chemical structure and ponents determination. 10) Study information and literature for quality specification. 11) Draft of quality specification and notes, and providing reference standard. 12) Test report of drug sample. 13) The source, test report and quality specification of drug substance and excipient. 14) Stability study and relevant literature. 15) Selection basis and quality specification of immediate packing material and container. C Pharmacology and toxicology study information. 16) Summary of pharmacology and toxicology study. 17) Primary pharmacodynamics study and literature. 18) General Pharmacology study and literature. 19) Acute/single dose toxicity study and literature. 20) Repeated dose toxicity study and literature. 21) Special safety study and literature of hypersensitive (topical, systemic and phototoxicity), hemolytic and topical irritative (blood vessel, skin, mucous membrane, and muscle) reaction related to topical and systemic use of the drugs. 22) Study and relevant literature on Pharmacodynamics, toxicity and pharmacokiics change caused by the interactions amongst multiple ponents in the bination products. 23) Study and literature of mutagenicity test. 24) Study and literature of reproductive toxicity. 25) Study and literature of carcinogenicity test. 26) Study and literature of drug dependence. 27) Study and literature of preclinical pharmacokiics. D Clinical Study Information 28) Summary of global clinical study information. 29) Clinical study protocol. 30) Investigator’s Brochure. 31) Draft of Informed Consent Form, approval of the Ethics Committee. 32) Clinical study report. III Notes to Application Information Items 1) Information Item 1, Name of the drugs, includes International Nonproprietary Name (INN), Chemical Name, English Name, and Chinese Phoics. Chemical structure, Molecular Weight, Molecular Formula shall be noted. The Nomenclature of the drug should be explained for any new name. 2) Information Item 2, Certified Documents, includes, i. Certified Documents of lawful registration of the Applicant, copies of Drug Manufacturing License, GMP Certificate. For the application of production of new drugs, copies of GMP Certificate for the workshop 13 / 57 where the sample product of the drugs was manufactured should be provided. ii. Certified Documents stating patent status and ownership of this entity and formula, production process of the drug, and letter of guarantee stating that no infringement upon the patent rights of others. iii. Copies of official approvals of the research proposal of narcotics, psychotropic, medicaluse toxic drugs and radioactive drugs. iv. For the application of production of new drugs, copy of Approval of Clinical Study of New Drugsand the quality standard of investigational drugs should be provided for the market authorization approval. v. For the application of production of preparation, certified documents to evidence the legal channels of drug substance should be provided, including copies of certified approval document of drug substance, drug standards, test report, business licenses of manufacturers of drug substance, Drug Manufacturing License, GMP Certificate,sales invoice, and supply contract. vi. Copies of the Drug Packing Material and Container Certificate or Import Drug Packing Material and Container Certificatefor the immediate packing material and container. 3) Information Item 3, objectives and basis of the application, includes Ramp。 – 24 * * * * * * * * * * * 25 + + ▲ + * * * * * – – 26 + + * * * * * * * – – 27 * * * * * * * * * – – 28 + – * – – – – – – – – Clinical trial information 29 + + + + + + + + + + – 30 + + + + + + + + + * – 31 + + + + + + + + + * – 32 + + + + + + + + + * – 33 + + + + + + + + + * – Notes: 1. + Denote the information must be submitted, 2. 177。 – 23 + + 177。 – 21 + + * + + 177。 – 20 + + * + + 177。 177。 177。 + + + + + + + – Pharmaceutical Information 14 + + 177。 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 o