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 2024

JAPAN / PMDA collaboration with PIC/S and WHO

Geneva, 10 April 2024:

At its meetings of May and November 2023, the PIC/S Committee welcomed the announcement made by Japan / PMDA that it would second one PMDA expert to the PIC/S Secretariat in Geneva (Switzerland).

Since 1 April 2024, Dr SUZUKI Hirofumi, PMDA, has been seconded to the PIC/S Secretariat where he is going to serve in order to facilitate PIC/S Secretariat activities including collaboration with the World Health Organization (WHO) with a view to strengthen regulatory capacity building in the Asian region (for more information, see link)

Dr SUZUKI will support the PIC/S Secretariat regarding the harmonisation of GMP standards and the training of inspectors for PIC/S Participating Authorities, especially in Asia. Dr SUZUKI has several years of experience in various PIC/S bodies as well as in participating in PIC/S on-site assessment visits. He will help supporting the operation of PIC/S activities with a focus on Asia.

PMDA has been a Member of PIC/S since 2014. This secondment represents an innovative way by PMDA to support PIC/S and it will help strengthen the PIC/S Secretariat in line with PIC/S’ Strategic Plan (2023-27).

January 2024

6th PIC/S Expert Circle Meeting on Good Distribution Practice (GDP)

Geneva, 30 January 2024:

The Department of Health and the Pharmacy and Poisons Board of Hong Kong (PPBHK) hosted the 6th PIC/S Expert Circle Meeting on Good Distribution Practice (GDP) from 29 November to 1 December 2023 via Zoom. A total of 230 participants joined the meeting. The meeting included discussions on contemporary issues and latest developments in the field of GDP and supply chain integrity; consolidating lessons learnt during COVID to support uninterrupted supply chain of medicine; sharing experiences between inspectors to improve consistency among inspectors in the field of GDP; and exchanging ideas and fostering collaboration among inspectorates. Follow us on LinkedIn.

January 2024

PIC/S-EMA-WHO Joint Implementation Working Group on Revised Annex 1 (manufacture of sterile medicinal products)

Geneva, 23 January 2024:

Friday, 19 January marked the inaugural kickoff meeting of the PIC/S-EMA-WHO Joint Implementation Working Group, bringing together experts from WHO, EMA, and PIC/S Participating Authorities. The goal is to achieve harmonized interpretation of the newly released PIC/S-EU GMP Annex 1 on Sterile Manufacturing. Follow us on LinkedIn.

January 2024

2024 Wishes and Video Message from New PIC/S Chairperson, Mr Jacques Morénas

Geneva, 15 January 2024:

The new PIC/S Chairperson for the period 2024-2025, Mr Jacques Morénas (France / ANSM), is pleased to share with you his 2024 greetings and best wishes in the following video message highlighting key PIC/S priorities and activities for the year coming.

November 2023

PIC/S Committee Meeting and Executive Bureau in Bangkok (Thailand)

The Thailand Food and Drug Administration (Thai FDA), Ministry of Public Health, hosted the following PIC/S events in Bangkok (Thailand) on 6-10 November 2023: PIC/S Committee Meeting, PIC/S Executive Bureau Meeting and PIC/S Annual Seminar.

The PIC/S Committee met on 6-7 November 2023, under the chairmanship of Mr Paul Gustafson (Health Canada). The meeting was attended by 37 out of 56 PIC/S Participating Authorities (PA) as well as by a number of Applicants, Pre-Applicants, and Associated Partner Organisations.