Geneva, 20 November 2023:
A new PIC/S Chairperson and Executive Bureau were elected as from 1 January 2024 by the PIC/S Committee at its meeting in Bangkok (Thailand) on 6-7 November 2023.
At this occasion, the PIC/S Committee unanimously elected Mr Jacques Morénas (France / ANSM) as Chairperson for the period 2024-2025. Mr Morénas will be assisted by Ms Kathleen Sinninger (US FDA), PIC/S Deputy Chairperson. The full Executive Bureau for the period 2024-2025 consists of:
The PIC/S Committee elected the Members, Deputy Chairs and Chairs of the PIC/S Sub-Committee structure for the period 2024-2025. Office holders were elected for the following seven Sub-Committees: Training (SCT); Expert Circles (SCEC); Strategic Development (SCSD); Compliance (SCC); GM(D)P Harmonisation (SCH); Budget, Risk and Audit (SCB) and Communication (SC COM). All Sub-Committee Chairs will be Members of the PIC/S Executive Bureau as listed above.
With more than 90 Sub-Committee Members for the period 2024-25, PIC/S has a truly global representation to support diverse perspectives that will help excel on its mission in the interest of public health.
Geneva, 16 July 2026:
The joint EMA - PIC/S drafting group has developed a concept paper on the revision of the Annex 15 (Qualification and validation) of the EU - PIC/S GMP Guide.
This concept paper aims to outline the rationale, objectives, and proposed changes for updating the Annex 15 - Qualification and validation, of the Good Manufacturing Practice (GMP) Guide, that is common to the Member States of the European Union (EU) / European Economic Area (EEA), as well as to the Participating Authorities (PAs) of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The aim of the revision is to extend the scope of the annex to active substances manufacturers and to consider the revision of ICH Guideline Q9 (R1) on quality risk management.
This concept paper was submitted to a joint EMA - PIC/S public consultation and comments have been collected until 9 April 2026. Following the public consultation, the initial timetable has been revised, and only this section has been updated accordingly.
The revised Concept Paper can be downloaded on the PIC/S website (link), as well as on the EMA website (link).
Geneva, 12 February 2026:
The joint EMA - PIC/S drafting group has developed a concept paper on the revision of the Annex 6 (Manufacture of medicinal gases) of the EU-PIC/S GMP Guide.
This concept paper aims to outline the rationale, objectives, and proposed changes for updating the Annex 6 - Manufacture of medicinal gases, of the Good Manufacturing Practice (GMP) Guide, that is common to the Member States of the European Union (EU) / European Economic Area (EEA), as well as to the Participating Authorities (PAs) of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).
The aim of the revision is to carry out a limited review and update of the guideline to reflect industry’s current practices, including the use of new technologies and computerized systems.
This concept paper is submitted to a joint EMA - PIC/S public consultation from 11 February 2026 until 11 April 2026 and can be downloaded on the PIC/S website (link) as well as on the EMA website (link).
Comments should be submitted via the EU Survey tool (link) in accordance with the PIC/S - EMA Harmonised Consultation Procedure.
Geneva, 10 February 2026:
The joint EMA - PIC/S drafting group has developed a concept paper on the revision of the Annex 15 (Qualification and validation) of the EU - PIC/S GMP Guide.
This concept paper aims to outline the rationale, objectives, and proposed changes for updating the Annex 15 - Qualification and validation, of the Good Manufacturing Practice (GMP) Guide, that is common to the Member States of the European Union (EU) / European Economic Area (EEA), as well as to the Participating Authorities (PAs) of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).
The aim of the revision is to extend the scope of the annex to active substances manufacturers and to consider the revision of ICH Guideline Q9 (R1) on quality risk management.
This concept paper is submitted to a joint EMA - PIC/S public consultation from 9 February 2026 until 9 April 2026 and can be downloaded on the PIC/S website (link) as well as on the EMA website (link).
Comments should be submitted via the EU Survey tool (link) in accordance with the PIC/S - EMA Harmonised Consultation Procedure.
Geneva, 10 February 2026:
On 20 March 2025, Kazakhstan’s Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare of the Republic of Kazakhstan (“CMPC”) and the State Enterprise on the right of economic management “National center for expertise of medicines and medical devices” (“NCEM”) of the Committee applied for PIC/S membership.
The application request was confirmed as complete at the PIC/S Committee meeting in Hong Kong (Hong Kong SAR, China) on 3-4 November 2025, further to which a Rapporteur and Co-Rapporteur were appointed.
Geneva, 3 February 2026:
The Ghana Food and Drugs Authority has applied for PIC/S pre-accession.
The pre-accession process started on 4 November 2025 following the appointment of a Rapporteur, which marks the start of the pre-accession process under the revised PIC/S pre-accession procedure.