欧盟GMP附录1《无菌药品生产》，拟今年初秋发布！

EU GMP Annex 1: When will the finalversion be released?

欧盟 GMP附录1: 最终版本何时发布？

It has been and continues to be speculated when the final version of Annex1 on the sterile manufacture of medicinal products will finally be published.At the beginning of this month, the issue was also discussed at the ISPE AnnualConference in Dublin. Dr. Sabine Paris from the editorial office of the GMP-Verlag was on site and brought these news with her:

一直以来都在讨论欧盟GMP无菌附录1何时发布终稿。本月初, 在都柏林举行的 ISPE 年会也讨论了这一问题。来自GMP-Verlag 编辑部的 Sabine paris 博士带来了这些消息:

In short: The publication of the final Annex 1 may be delayed until earlyautumn. There are several reasons for this:

简而言之：无菌附录1的终稿可能会推迟到初秋发布。造成这种情况的原因有几个：

• Andrew Hopkins, Expert     GMDP Inspector and Chairman of the EMA/PIC/S Annex 1 Working Group, left     the MHRA in December 2018.

  GMDP 专家检查员兼 EMA/PIC/S 附录1工作组主席 Andrew     Hopkins 于2018年12月离开 MHRA。

• The GMP/GDP Inspectors     Working Group (IWG) has now 'moved' to Amsterdam, which has led     to further work delays. Due to the relocation of the EMA to Amsterdam, all     EMA activities will be severely restricted until June 2019. For example,     no on-site meetings of the various working groups will take place until at     least September 2019.

  GMP/GDP检查员工作组现已 '迁往' 阿姆斯特丹, 导致进一步的工作拖延。由于EMA 搬迁到阿姆斯特丹, 所有 EMA 活动将严格受限, 一直到2019年6月。例如, 各工作组至少要到2019年9月才能举行现场会议。

• For Annex 1, 6200     comments were received from 140 different contributors.

  关于附录 1, 收到了140个不同方的6200份意见。

So we just have to keep practicing patience!

所以我们只要保持耐心就可以了！

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