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, led by Francesco Cicirello, Australia / TGA, and by the PIC/S Sub-Committee on GMDP Harmonisation, led by Paul Gustafson, Health Canada. 

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; and
    -    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). 

This consultation will also allow PIC/S to collect feedback from stakeholders to help PIC/S develop its thinking in this area. PIC/S recognises that this is a rapidly developing industry and the revision being developed represents an intention of PIC/S to consider: 

   -    issues that stakeholders including (academia, hospitals, subject matter experts or the pharmaceutical industry SMEs)
        are facing in the international context; and

   -    how harmonised international GMP standards can help to facilitate manufacturing of these products, especially in
        consideration of the increasing manufacturing that occur cross-border. 

The consultation period will last 3 months and run from 20 September 2019 to 20 December 2019.

To download the Consultation Notice (PS/INF 24/2019) and the Draft Annexes 2A and 2B (PS/INF 25/2019 (Rev. 1) and PS/INF 26/2019 (Rev. 1)) please consult the page “Publications” or click on the links below:

PS INF 25 2019 (Rev. 1) Draft Annex 2A (Manufacture of ATMP) to PICS GMP Guide for Public Consultation.pdf

PS INF 26 2019 (Rev. 1) Draft Annex 2B (Manufacture of biological medicinals) to PICS GMP Guide for Public Consultation.pdf