【正文】 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。D in China and overseas, current clinical use and production summary, necessary analysis as for the innovation, feasibility, and rationale of dosage form, including the parison with similar drug already with National Standard, should be provided for preparation of TCM and natural drug. For TCM, traditional medical theory and ancient drug book should also be provided. 5 / 57 4. Information Item 4, summary and evaluation of main research results, includes the summary of main research results by the Applicant, and a prehensive analysis of safety, efficacy, and quality controllability of the drugs of the application. 5. Information Item 5, draft of insert sheet, notes to the draft and latest literature, includes the sample of draft of packaging insert sheet drafted in accordance with the relevant regulations, notes on how each items of the insert sheet were drafted, latest relevant literature. Summary of Pharmaceutical Study 6. Information Item 16, self test report: refer to the self test repot of sample, report for at least one batch should be provided when applying for clinical trial, upon pletion of clinical trial, self test report of 3 batch of project should be provided when submitting the dossier. Summary of pharmacology and toxicology Study 7. Information Item 24 of hypersensitive (topical, systemic and phototoxicity), hemolytic and topical irritative (blood vessel, skin, mucous membrane, and muscle) reaction, Experiments information and literature related to topical and systemic use of the drugs: Experiments information of safety of preparation should be provided according to the details of the route of administration and preparation. When there is a tendency of drug dependence, experiment data related to drug dependence should be provided. 8. information item 25: Experiments information and literature related to genotoxicity: if the formula include drug material not yet collected in statutory drug standards, or from the active part of drug material not yet collected in statutory drug standards, or new drug to be used for the child bearing patient group where it act on reproductive system (such as contraceptives, sexual hormones, drugs for sexual function disorder