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

January 2023

Adoption and Entry into force of New GDP Guidance Documents

PIC/S has published the following two guidance documents for GDP inspectors: an ‘Aide-Memoire on the Inspection of Good Distribution Practice for Medicinal Products in the Supply Chain’ (PI 044-1) and a ‘Questions & Answers (Q&A) document regarding the PIC/S GDP Guide’ (PS/INF 22/2017). These documents have been prepared by the PIC/S Expert Circle on GDP, led by Karen Ford (South Africa / SAHPRA), and will enter into force on 1 February 2023. They are available for downloading on the page “Publications”.

November 2022

Concept Paper on the revision of EU-PIC/S GMP Annex 11 (Computerised Systems)

Geneva, 17 November 2022:  A dedicated European Medicines Agency (EMA) Drafting Group, in which PIC/S is represented by Ib Alstrup (Denmark / DKMA), who is also the Chair of the PIC/S Working Group on the revision of PI 011 (PIC/S Recommendation on Computerised Systems), has developed a concept paper on the revision of Annex 11 (computerised systems) of the EU-PIC/S GMP Guide.

This concept paper is submitted to a joint PIC/S-EMA public consultation from 16 November 2022 until 16 January 2023 and can be downloaded on the PIC/S website ( ) as well as on the EMA website (,-reflection-papers-and-draft-guidelines-section )

Comments should be sent to using the EMA template downloadable via the link provided in the Concept Paper by 16 January 2023.

October 2022

PIC/S 50th Anniversary

Geneva, 14 October 2022: The Pharmaceutical Inspection Co-operation Scheme (PIC/S) celebrated its 50th anniversary at a special symposium in Dublin (Ireland) on 4 October 2022. Since the first meeting of the PIC Committee in 1972, PIC/S has come a long way! The symposium titled “Thriving at 50 and Striving Forward” aimed at promoting and highlighting PIC/S’ contributions to international collaboration and co-operation while being resolutely turned towards the future.

The symposium was opened by Ireland’s Health Products Regulatory Authority (HPRA) Chief Executive, Ms Lorraine Nolan, who was hosting. The PIC/S Chairperson, Mr Paul Gustafson (Health Canada) presented on PIC/S new strategic plan for 2023-2027 while the PIC/S Deputy Chairperson, Ms Susan Laska (US FDA), outlined the evolution of pharma industry and PIC/S. The keynote speaker, Ms. Emer Cooke, Executive Director of the European Medicines Agency (EMA), addressed how to strive for better international relationships and collaboration. The programme comprised a wide range of presentations and panel discussions on inspection-related topics, which included participation from Heads of Medicines Agencies, Heads of GMDP Inspectorates and official PIC/S representatives.

Close to 200 participants from all continents participated in the event, including most of PIC/S 54 Participating Authorities and 7 (Pre-)Applicant Authorities, PIC/S Associated Partner Organisations (European Commission, EDQM, EMA, UNICEF, WHO and WOAH) as well as a number of non-PIC/S Competent Authorities. The anniversary also provided a unique opportunity to meet and engage with a range of invited stakeholders present for the occasion and to reconnect with the wider PIC/S network. A more detailed press release will follow covering also PIC/S meetings and 2022 Annual Training Seminar, which took place in Dublin back-to-back with the anniversary symposium.

> To the new PIC/S Strategic Plan (2023-2027)

> To the Anniversary Programme

> To the Anniversary Group Photo

> To the Anniversary Promotional Video

September 2022

The European Commission (DG SANTE) becomes a new PIC/S Associated Partner Organisation

Geneva, 29 September 2022: The PIC/S Committee has granted the status of Associated Partner Organisation to the European Commission’s Directorate-General for Health and Food Safety (DG SANTE).

Recognising that they share a common goal to protect public and animal Health and Safety, PIC/S and DG SANTE have agreed to enter into a working arrangement to co-operate in areas of common interest. The co-operation will notably be on Good Manufacturing and Distribution Practice (GMDP) standards and their implementation processes for medicinal products for human or veterinary use with a view to make best use of available resources and avoid duplication of activities. DG SANTE has very close relations and interactions as part of the EU Regulatory Network with the European Medicines Agency (EMA), which has its own co-operation agreement with PIC/S. Also the Heads of Medicines Agencies of the European Economic Area (HMA) have signed a letter of agreement with PIC/S in 2016. The co-operation between PIC/S and DG SANTE under this new arrangement will be complementary to those co-operations.

This new bilateral co-operation arrangement will lead to opportunities for increased international co-operation and is very much in line with similar agreements that PIC/S has signed with other associated partners such as EMA, EDQM, UNICEF, WOAH and WHO. Along with this new co-operation arrangement, a new trilateral working arrangement on the exchange of non-public information between PIC/S, EC and EMA has also been signed.

An official welcome will be given to DG SANTE at the next PIC/S Committee meeting in Dublin (Ireland) on 3 October 2022.

September 2022

Publication of revised PIC/S Annex 1

The revised Annex 1 to the PIC/S GMP Guide on the manufacture of sterile products has been published and will enter into force on 25 August 2023, except for point 8.123 which is postponed until 25 August 2024. The date of entry into operation is aligned with that of the revised EU Annex 1, which is identical to PIC/S Annex 1 (with some very minor editorial differences).

The entry into force closes a long revision process, which has been driven jointly by PIC/S and the EMA Inspectors’ Working Group (IWG) on GMDP in close co-operation with the European Commission (EC) and the World Health Organization (WHO). This has been a best-in-class model of international co-operation between EC, EMA, WHO, and PIC/S.

Annex 1 was first published in 1971 based on a PIC/S recommendation to ensure the sterility of medicinal products for the benefits of patients. It has undergone a number of partial revisions since its publication. This is, however, the first full revision aiming at restructuring this Annex, adding clarity to the requirements on the sterile manufacturing of medicinal products and introducing the principles of Quality Risk Management to allow for the inclusion of new technologies and innovative processes.

PIC/S decided to establish a Working Group on Annex 1 at its Rome meeting on 15-16 May 2014. It was then merged with the EMA IWG Drafting Group with a view to jointly revise Annex 1. WHO also decided to join the revision process with a view to align Annex 1 to the WHO GMP Guide. The joint Working Group included representatives of the Competent Authorities of PIC/S and EEA as well as WHO. The Working Group was first chaired by Andrew Hopkins (UK / MHRA) and then by Abdelaali Sarakha (France / ANSM).

Following two written consultations of Competent Authorities, the revision of Annex 1 was submitted to joint public consultation in December 2017. Over 6,300 comments were received during the 3-month consultation and then reviewed by the Working Group in 2018-19. This resulted into a new draft of the revised Annex 1, which was submitted to a second joint consultation from February to July 2020, during which approximately 2,000 comments were received and then reviewed by the Working Group in 2020-21.

The revised Annex 1 was then submitted to adoption to the EMA IWG on GMDP and the PIC/S Committee on 1 March and 29 April 2022, respectively. It has then been published by the EC on Eudralex and by PIC/S on the PIC/S website.