【正文】 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. 22) Experiments information and literature of acute toxicity. 23) Experiments information and literature of long term toxicity. 24) 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. 25) Research information and literature of genotoxicity 26) Study and literature of reproductive toxicity. 27) Study and literature of carcinogenicity test. 28) Study and literature of animal pharmacokiics. Clinical Study Information 29) Summary of clinical study. 30) Clinical study plan and protocol. 31) Investigator’s Brochure. 32) Sample draft of Informed Consent Form, approval of the ethics mittee. 33) Summary report of the clinical study. II Notes A, notes to application information items Summary information 1. Information item 1, drug name include, i) Chinese name ii) Phoic name iii) Nomenclature of the drug 2. Information item 2, certified document include, 4 / 57 i) Certified Documents of lawful registration of the Applicant, copies of Drug Manufacturing License, GMPCertificate. For the application of production of new drugs, copies of GMPCertificate for the workshop 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 ofApproval of Clinical Study of New v) Copies of the Drug Packing Material and Container Certificateor Import Drug Packing Material and Container Certificatefor the immediate packing material and container vi) Other certified documents. If it is importation, the following are also required i) Certified Documents, notarized document for the free sale certificate (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。 177。 – 20 + + * + + 177。 – 23 + + 177。 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