Consultation on revised draft PIC/S GMP Guide Annex 2A and Annex 2B

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 2A (PS/INF 25/2019 (Rev. 1)): Manufacture of Advanced Therapy Medicinal Products for Human Use;

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.

See: https://picscheme.org/en/news

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)