COS简介(修改)演示文稿.pptVIP

COS简介 技术性资料的要求 背景信息 主要参考 * * ?COS（Certificate of Suitability）指的是欧洲药典适用性认证，欧洲药典委员会即欧洲药物质量理事会（EDQM）颁发的用以证明原料药品的质量是按照欧洲药典有关专论描述的方法严格控制的, 其产品质量符合欧洲药典标准的一种证书。 目的：是考察欧洲药典是否能够有效地控制进口药品的质量，这种注册途径的优点是不依赖于最终用户，可以由原料药生产厂商独立地提出申请。 COS证书在我国原料药出口中的意义是：作为最终用户的欧盟成员国制剂生产企业如果决定采用中国生产的原料时，只要在上市申请文件或原料变更申请文件中附上该产品的COS证书复印件即可很快获得批准。 Scope and status Is the CEP mandatory for marketing a substance in EU countries?No. The CEP is not a mandatory requirement in Europe for marketing substances, but is the preferred option to demonstrate that a substance used in the preparation of medicinal products comply with the European Pharmacopoeia specifications according to the Note for Guidance on summary requirements for active substances in the quality part of the dossier (CPMP/QWP/297/97 Rev 1; EMEA/CVMP/1069/02). The role of the CEP is to demonstrate that the purity of a given substance is suitably controlled by the relevant monograph(s) of the European Pharmacopoeia. By demonstrating that they have been granted a CEP for their substance, suppliers of raw materials can prove this suitability to their pharmaceutical industry clients and/or the licensing authorities. A copy of a CEP is then sufficient in a marketing application dossier to replace:- Documentation related to drug substance as described in Common Technical Document NTA, Vol.2 B-CTD module 3.2.5, implemented on the 1st July 2003 or EDMF.Note that technical information (such as functionality tests, stability data when a retest period is not mentioned on the Certificate) is not covered by the CEP. It may be required by licensing authorities and marketing authorisation holder and should be a part of the marketing authorisation application dossier;- All the information to be provided concerning TSE risk evaluation (TSE CEP). 在欧盟范围内销售原料药是否必须要有COS 证书？ 答：不是。 法律上并没有要求在欧洲销售原料药一定要有COS 证书，但任一种用于制剂生产的原料药必须符合一定的质量标准，如欧洲药典标准。COS证书的作用在于说明相关原料药的质量根据欧洲药典质量标准得到了很好的控制。若供应商持有相关原料药的COS证书，则他可以向制药企业客户及药品管理部门证明原料药的质量。 COS证书的复印件足以代替药品上市申请文件中的质量部分或EDM