News

September 2019

Focused stakeholders consultation on revised draft PIC/S GMP Guide Annex 2A (Manufacture of Advanced Therapy Medicinal Products for Human Use) and Annex 2B (Manufacture of Biological Medicinal Substances and Products for Human Use)

Geneva, 20 September 2019: 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 (Canada / ROEB). 

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 submit feedback, please provide feedback exclusively on the dedicated Consultation Notice (PS/INF 24/2019) and submit in Word format (not PDF) by e-mail with subject line "PIC/S Focused Public Consultation - Revision Annex 2" to one of the following associations which will collect and compile responses. Stakeholders should only reply once. 

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 24 2019 Consultation Notice Revision Annex 2

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

April 2021

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

January 2021

Jordan applies for PIC/S membership

Geneva, 26 January 2021: On 20 January 2020, Jordan Food & Drug Adminstration (JFDA) submitted a complete membership application to PIC/S. 

The Rapporteur(s) will be appointed either by written procedure or at the next PIC/S Committee meeting.

January 2021

Revision of PIC/S Aide Memoires (PI 009-4; 024-3; 028-2; 038-2)

Geneva, 19 January 2021: the following PIC/S guidance documents have been revised:

  • PI 009-4 Aide Memoire on Utilities
  • PI 024-3 Aide Memoires on Biotech
  • PI 028-2 Aide Memoire on Packaging
  • PI 038-2 Aide Memoire on Assessment of QRM Implementation

The revision process consisted in updating the cross-references to the PIC/S GMP Guide. No other changes were made. The revised Aide Memoires enter into force on 1 January 2021.

 To download the revised Aide-Memoires, please consult the page “Publications

January 2021

Russia applies for PIC/S membership

Geneva, 13 January 2021: On 22 December 2020, the Competent Authorities of the Russian Federation submitted a complete membership application to PIC/S.  The Russian Competent Authorities are:

  • Ministry of Industry and Trade of the Russian Federation (Minpromtorg Russia)
  • Federal Service for Surveillance in Healthcare (Roszdravnadzor), including Federal State Budgetary Institution “Information and Methodological Center for Expertise, Accounting and Analysis of Circulation of Medical Products” (FGBU “IMCEUAOSMP” of Roszdravnadzor)
  • Federal State Institution “State Institute of Drugs and Good Practices” (FSI “SID & GP”)
  • Federal State Budgetary Institution "Scientific Center for Examination of Medical Devices" of the Ministry of Health of the Russian Federation (FSBI ''SCEMD”)

The Rapporteur(s) will be appointed either by written procedure or at the next PIC/S Committee meeting.

November 2020

Brazil / ANVISA joins PIC/S

Geneva, 30 November 2020 :  The PIC/S Committee has invited Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) to join the PIC Scheme.

Brazil / ANVISA will become PIC/S’ 54th Participating Authority as from 1 January 2021. ANVISA submitted a complete membership application in October 2014. A paper assessment was carried out followed by an on-site assessment visit which took place in October 2019, after a reorganisation at ANVISA. The assessment report was finalised in the course of 2020. The Audit team recommended to the Committee to accept the PIC/S membership application of ANVISA. After endorsement by the PIC/S Sub-Committee on Compliance (SCC), the PIC/S Committee then unanimously decided by written procedure completed on 27 November 2020, on the participation of ANVISA in PIC/S.

This is the first time in PIC/S’ history that an assessment process is completed by written procedure rather than at a Committee meeting. This was due to the situation with Covid-19 which prevented a Committee meeting taking place in 2020. A special welcome will be given to ANVISA at the next PIC/S virtual Committee meeting in 2021.