中外保健食品管理制度比较-杨悦0612.ppt

进口中国保健食品注册申报资料要求Import health food registration materials requirements in China 除前述要求外，还应提供 Except preceding requirements, should also submit GMP 证明文件 GMP compliance certificate 驻中国代表机构或注册代理机构证明 China representative agency and registration agent qualification 在生产国生产一年以上的证明（公正并确认） Evidence that has been produced in original country (notary and affirm) 产品标准 Product standard 在生产国（地区）上市使用的包装、标签、说明书实样 Packaging, labling,package insert sample in original country 连续三个批号样品，检验量的三倍 3 batches sample in a raw, trice test volume ? 2010 Shenyang pharmaceutical university * 申请的功能不在27种功能范围内应提供的其他资料Materials should be submitted when claims not included in 27 functions 功能研发报告Function research and development report 功能名称 Function definition 申请理由和依据 application reason and basis 功能学评价程序 functional assessment process 检验方法 analysis methods 研究过程和相关数据 research procedure and relate data 建立功能学评价程序和检验方法的依据和科学文献资料等；basis and scientific documents for establish functional assessment process and analysis methods 功能学自检报告 functions test report 确定的检验机构出具的验证报告 test and verify reports by specific test agency ? 2010 Shenyang pharmaceutical university 膳食补充剂上市不需FDA审批Dietary supplement do no need approval from FDA before they are marketed. 含有新膳食成分时，上市前制造商提供产品安全性数据及相关信息的综述 Except in case of a new dietary ingredient, where pre-market review for safety data and other information is required by law 主要是物质与疾病的关系的公开可获得的数据和书面信息 considers the publicly available data and written information pertaining to the relationship between a substance and disease. 不含新膳食成分不需要提供相关证据 Not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products if no new ingredients 制造商和分销商应提供文件说明所销售的膳食补充剂成分在1994年10月15日前已经得到使用 Manufacturers and distributors are responsible for determining if a dietary ingredient is “New”, and if it is not, for documenting that the dietary supplements its sells, containing the dietary ingredient, were marketed before Oct.15,1994.