【文章內(nèi)容簡介】 , drugs for maturation promoting of sperm, the new drugs with positive result in mutations test or drugs with cytotoxicity), genotoxicity test data should be provided. 9. information item 26, Experiments information and literature related to reproductive toxicity: for new drug to be used for the child bearing patient group where it may act on reproductive system (such as contraceptives, sexual hormones, drugs for sexual function disorder, drugs for maturation promoting of sperm, the new drugs with positive result in mutations test or drugs with cytotoxicity), reproductive toxicity test data should be provided according to the specific situation. 10. information item 27, Experiments information and literature related to carcinogenicity: during long term toxicity test of a new drug if cytotoxic effects were shown or extraordinary activation on the growth of cells in certain visceral ans and tissues were caused, or there is a positive test result during mutagenicity test, then experiments information and literature related to carcinogenicity must be provided. B, requirement for application dossier, 6 / 57 1. Information item 14 and 731 should usually be summated for application for clinical trails of new drug. 2. for application for production upon pletion of clinical trial, information item 133 as well as other changes and supplemental information should be submitted with detailed explanation of reason and basis. 3. information item 28, 12 and 1518 should be usually submitted for application of generic drugs(except for TCM or natural drug injection where clinical trail is needed). 4. all technical information and certified document from local authority used for importation application should be in Chinese attached with original document, where Chinese version of quality standard should be plied and submitted according to the format specified by Chinese National drug standards. 5. as for the plexity and diversity of TCM and natural drugs, when making the application, necessary research should be conducted according to the specific drug. If there is need for reduction or exemption of tests, there should be sufficient justified reasons. 6. technical requirement of TCM and natural drug injection should be separately promulgated. 7. for the drug of category 1, active ingredients and its preparation extracted from plant, animal and minerals, which have not been marketed in China, if the active ingredients is related to the known carcinogen or the metabolite of the new drugs are similar to the known carcinogen, or if the expected treatment period is longer than 6 months, or used for treatment of chronic and recurrent disease, or intermittent use for a regular period of time, then experiments information and literature related to carcinogenicity must be provided. for the application for active ingredients and its preparation extracted from plant, animal and minerals, which have not been marketed in China, if there is similar drug or preparation made from active part extracted from single plant, animal and minerals, which have been marketed in China, then there should be parison between the drug and the existing part to evidence the advantage of the new drug. 8. for the substitute of TCM material under registration category 3, in addition to the preclinical submission requirement of registration category 2, the experiment data of Pharmacodynamics parison between this drug and the substituted drug should also be provided, while experiment and information of human tolerance test and clinical bioequivalence test of the related preparation should be provided as well. If the substitute is a single ponent, experiment and literature of Pharmacokiic test may be provided. after the approval of the substitute of the TCM material, application for preparation of this substitute should follow the procedure of supplemental application, but must be strictly within the approved scope of substitution. 9. for those 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, which are under “registration category 5”, in addition to the required application information, the following information are also required to be submitted, i) research information or literature related to the screening of the active parts as required by information items 12, research information or 7 / 57 literature related to major chemical content of the active parts as required by information items 13. ii) If the active parts is prised of multiple ponents, each of the ponents should be assayed, where there should be lower limit of representative value for each ponents (upper limit should be added for the toxic ponent as well). iii) When applying for new active part of material to be used as drugs and its preparation, which are prised of similar content and extracted from plant, animal and minerals and have not been marketed in China, if it is prised of active ingredient extracted from plant, animal and minerals that already marketed in China, pharmacodynamic parison and other parison should be conducted with this active ingredient to evidence the advantage and merit. 10. the required information for those under “registration category 6” that TCM, natural drugs and its bined preparation not yet marketed in China are different for different situation: i) bined preparation of TCM, some experiment data may be exempted according to the source of formula, indication and preparation process. ii) Experiment and literature of efficacy and interaction of multiple ponent should be provided for bined preparation of natural drug. iii) If the formula include drug not listed in the statutory drug standards, additional applic