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标题: 20151022 ECA新闻：研究用药---EC指南里最新变更 [打印本页]

作者: 淡定 时间: 2015-10-29 11:57 AM
标题: 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

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/

作者: 哈雷 时间: 2015-10-29 02:00 PM
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