进口(含港、澳、台)化学药品a临床试验批准.docx.review.docxVIP

进口（含港、澳、台）化学药品临床试验批准Approval for clinical trials of imported (incl. from Hong Kong, Macao and Taiwan) chemicals2012年11月05日发布一、项目名称：进口药品注册I. Project name: Imported Drug Registration二、许可内容：进口（含港、澳、台）化学药品临床试验批准，其分类按《药品注册管理办法》附件二注册分类，即：II. Content of licensing: Approval for clinical trials of imported (including Hong Kong, Macao and Taiwan) chemicals, which are classified in accordance with Annex II of the “Provisions for Drug Registration”, namely:注册分类1、未在国内外上市销售的药品。RegistrationCategory 1, drugs not marketedathomeandabroad.注册分类3、已在国外上市销售但尚未在国内上市销售的药品。RegistrationCategory 3, drugsthathavebeenmarketedoverseasbutnotyetinthedomesticmarket.三、实施依据：《中华人民共和国药品管理法》、《中华人民共和国药品管理法实施条例》、《药品注册管理办法》III. Legal basis: Drug Administration Law, Regulations for Implementation of the Drug Administration Law,” and “ProvisionsforDrugRegistration”四、收费：IV. Charges:进口药审评及审批收费45300元Reviewandapprovalfeeforimported drugs: RMB45,300yuan收费依据：《国家计委、财政部关于调整药品审批、检验收费标准的通知》〔计价格（1995）340号〕Chargingbasis: Notice of the State Planning Commission and the Ministry of Finance on the Adjustment of Fees for Drug Review, Approval and Tests [J.J.G. (1995) No.340]五、数量限制：本许可事项无数量限制V. Quantity restrictions: No quantity limit forthislicensing六、申请人提交材料目录：VI. List of application dossiers:《进口药品注册申请表》Application Form for the Registration of Imported Drugs”（一）综述资料(I) Summary data1.药品名称。a) Name of drug;2.证明性文件。b) Approval documents;3.立题目的与依据。c) Objective and rationale for the study;4.对主要研究结果的总结及评价。d) Summary and evaluation of study results;5.药品说明书、起草说明及相关参考文献。e) A draft of insert sheet, notes to the draft and the latest literatures;6.包装、标签设计样稿。f) Draft of the designed package and label.（二）药学研究资料(II) Pharmaceutical research data7.药学研究资料综述。g) Overview of pharmaceutical research data.8.原料药生产工艺的研究资料及文献资料；制剂处方及工艺的研究资料及文献资料。h) API production process research data and literature; drug formulations and processes research data and literature.9.确证化学结构或者组份的试验资料及文献资料。i) Testing data and literature for confirmation of chemical structur