20151022 ECA新闻：研究用药---EC指南里最新变更

20151022 ECA新闻：研究用药---EC指南里最新变更  

GMP News
22/10/2015

Investigational Medicinal Products - Recent Changes in EC Guidance

研究用药---EC指南里最新变更

As we reported before in our IMPs: Four new public consultations concerning GMP and GCP publishedthe implementation of the Clinical Trial Regulation 536/2014 resulted in four new public consultations concerning good manufacturing practices and clinical trials for human medicinal products (opened August 28, 2015) with closing date November 24, 2015.

正如我们以前报道的，临床试验法规536/2014的实施引发了4个新的关于人用药优良生产规范和临床试验的公众咨询（2015年8月28开始），截止日期为2015年11月24日。

As a consequence Annex 13 is expected to be deleted from EudraLex Vol 4 when the new guidelines "Detailed Commission guidelines on GMP for IMPs for human use" become operational. It carries over relevant principles of Annex 13.

结果就是预期在新的指南“人用IMP的GMP详细委员会指南”运行后，会将附录13从欧盟药事法卷4里删除。它继承了附录13里相关原则。

Basically the ideas are the same. However there is more detail in regard of

基本上来说，其观点是相同的。但是，还是有更多细节：

• the pharmaceutical quality system and handling deviations by CAPA
• 药品质量体系和采用CAPA处理偏差
• supplier approval
• 供应商批准
• quality risk management principles
• 质量管理原则
• final certifying by the qualified person
• 最终由授权人认证
• the retaining period of batch records
• 批记录的保留时间
• reference and retention samples.
• 对照品和留样
  

On the European QP Assocaition website you can find a Synopsis of  Annex 13 / "Detailed Commision guidelines for GMP for IMPs for human use". There you will also find a summary which contains links to the most recent changes being published for consultation.

在欧洲

QP

协会网页上，你可以找到附录

13/

“人用

IMP

的

GMP

详细委员会指南”的大纲。在那里你也可以找到摘要，其中包括了大多数最近有变更公布征求意见的链接。

转载自：http://zhuyujiao1972.blog.163.com/blog/static/98694727201592210535367/

谢谢楼主分享！