2021版 PIC/S 法规正文和附录-英文版

wwm · 发表于 2021-4-30 19:15:35

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PE 009-15 GMP Guide (Intro).pdf (177.33 KB, 下载次数: 63)

罗伊鲱 · 发表于 2021-5-2 10:10:47

本帖最后由厕所所长于 2021-5-2 09:57 编辑

Revision of PIC/S GMP Guide (PE 009-15)

Geneva, 23 April 2021: The PIC/S GMP Guide to Good Manufacturing Practice (GMP) for Medicinal Products has been revised to include a new Annex 2A and 2B:

Annex 2A: Manufacture of Advanced Therapy Medicinal Products for Human Use (ATMP); and
Annex 2B: Manufacture of Biological Medicinal Substances and Products for Human Use

Annex 2A provides PIC/S GMP requirements for ATMP - it is not a standalone document but it enables reasonable harmonisation with the standalone ATMP Guidelines published by the European Commission. Annex 2B had very minor revisions and continues to harmonise with the EU Annex 2 for human use biological medicinal substances and products.

The revision has been successfully completed by the PIC/S Sub-Committee on the Harmonisation of GM(D)P, led by Paul Gustafson (Canada / ROEB), based on the work of the PIC/S Working Group on Annex 2. This Working Group was led by Francesco Cicirello (formerly with Australia / TGA) until May 2020 and then by Christina Meissner (Austria / AGES), who finalised the revision.

The revised GMP Guide (PE 009-15), with the new Annex 2A and 2B, will enter into force on 1 May 2021. All non-EEA Participating Authorities of PIC/S and Applicants have been invited to transpose the revised Chapters of the PIC/S GMP Guide into their own GMP Guides.

To download the revised GMP Guide (PE 009-15), please consult the page “Publications”

故x原野 · 发表于 2021-5-1 18:29:09

谢谢分享

小金库 · 发表于 2022-8-6 21:36:13

感谢分享。

曾祥敏 · 发表于 2023-2-16 20:48:23

谢谢分享谢谢分享谢谢分享

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