A
draft revision of the PIC/S GMP Guide Annex 2 (Manufacture of biological
medicinal substances and products for human use) has been prepared by the PIC/S
Working Group on revision of Annex 2 established with WHO. This revision is
subject to a focused stakeholder consultation which includes both consultation
questions and an opportunity to comment on:
A
draft Annex 2B (PS/INF 26/2019 (Rev. 1)): Manufacture of Biological Medicinal
Substances and Products for Human Use.
Draft
Annex 2A takes into account the international development in the regulation of
Advanced Therapy Medicinal Products (ATMP) with particular attention to the
European Commission guideline on GMP for ATMP which has been published since
the latest revision of the EU Annex 2, while addressing at the same time
concerns of PIC/S Participating Authorities with regard to patient safety and
proportionate regulation for ATMPs.
Draft
Annex 2B is the revised version of EU Annex 2 for biologics (excluding
ATMPs). The consultation period will
last 3 months and run from 20 September 2019 to 20 December 2019.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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