ECA新闻：展望：2016年GMP有何新进展？

julia朱玉姣

GMP News
10/02/2016

Outlook: What will bring the GMP Year 2016?

展望：2016年GMP有何新进展？

The previous year 2015 was an eventful year. Again there were new developments in the GMP environment as well as announcements of changes that preoccupied the pharmaceutical industry. 2016 won't be less exciting, also because now many of the new requirements must be implemented. But aso novelties have to be expected. Here are a few highlights:

之前的2015年是多事的一年。在GMP环境再次有新的发展，制药行业也有不少变化宣布。2016年也不会差，也因为现在许多新的要求必须实施了。还有一些创新值得期待。这里讲一些重点内容。

A new Annex might be added to the EU GMP Guide: Annex 21 for "Importers of Medicinal Products". The current concept paper doesn't reveal much information but a first draft of the new Annex can be expected soon for public consultation. The discussions of the requirements for import in the context of the revision of Annex 16 ("Certification by a QP and Batch Release") were the impulse for the new document. The future Annex is aimed at importers and will cover requirements regarding import activities which are not part of other GMP regulations so far.
EU GMP指南中可能会增加一个新的附录：附录21“药品进口商”。目前的概念文章并没有透露出许多信息，但可以期待新附录的第一版草案会很快公布征求意见。在附录16（QP证明和批放行）修订后，对进口要求的讨论是新文件产生的原因。将来的附录针对的是进口商，会包括关于进口活动的要求。这些进口活动截止目前并不在其它GMP法规里面。

A concept paper on Annex 1 of the EU GMP Guide (Manufacture of sterile Medicinal Products) is currently running. A first draft of the revised Annex should also be expected soon for public consultation. The revision is not supposed to create new expectations, but it will contain some adjustments like for example the consideration of other international sets of rules (FDA Aseptic Guide, ICH Q8, Q9, and Q10) and the clarification of requirements which have been until now controversial or ambiguous.

野性之吻

路在何方？

ravenhigh

未来GMP不会是重点了，GMP不过是保证药品“安全”，下一步是“有效”

syhorchid

看一步，走一步。

北重楼

药品的终极保证是安全、有效