【正文】 f 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. 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 ce