Geneva, 12 June 2023:
A new PIC/S Deputy Chairperson and a new PIC/S Sub-Committee on Strategic Development (SCSD) Chair took office on 11 May 2023. Due to the retirement from her Agency of the former PIC/S Deputy Chairperson and SCSD Chairperson, Susan Laska (US FDA), the PIC/S Committee carried out by-elections at its last meeting in Geneva on 11-12 May 2023. It unanimously elected Mr Jacques Morénas (France / ANSM) as new PIC/S Deputy Chairperson - in addition to his current position of PIC/S Sub-Committee on Training (SCT) Chair - and elected Ms Jennifer Burnett (Australia / TGA) as new PIC/S Sub-Committee on Strategic Development (SCSD) Chair. All other Executive Bureau Members remain the same.
With these changes, the new composition of the Executive Bureau for the remaining of the period 2022-2023 consists of:
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.
Geneva, 1 January 2026:
On 1 January 2026, the Jordan Food & Drug Administration (JFDA) became the 57th PIC/S Participating Authority.
JFDA submitted a complete membership application in January 2021, after successfully completing the pre-accession process. A paper assessment was carried out followed by an on-site assessment visit, which took place in April 2025. The Audit team recommended to the Committee to accept the PIC/S membership application of JFDA. After endorsement by the PIC/S Sub-Committee on Compliance (SCC), the PIC/S Committee then unanimously decided at its meeting in Hong Kong on 3-4 November 2025 on the participation of JFDA in PIC/S as of 1 January 2026.
Geneva, 16 December 2025:
The joint EMA - PIC/S drafting group has developed a concept paper on the revision of the Annex 3 (Good Manufacturing Practice for Radiopharmaceuticals) of the Good Manufacturing Practice (GMP) Guide.
This concept paper aims to outline the rationale, objectives, and proposed changes for updating the Annex 3, Manufacture of Radiopharmaceuticals, 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 provide guidance within some areas that were not covered in the current version issued in 2008, clarify some sections, and support innovative pharmaceutical manufacturing and control approaches.
This concept paper is submitted to a joint EMA - PIC/S public consultation from 15 December 2025 until 15 February 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, 4 November 2025:
A new PIC/S Chairperson and Executive Bureau were elected as from 1 January 2026 by the PIC/S Committee at its meeting in Hong Kong SAR, China, on 3 November 2025.
At this occasion, the PIC/S Committee unanimously elected Ms Kathleen Sinninger (US FDA) as Chairperson for the period 2026-2027. Ms Sinninger will be assisted by Mr Gwylim Janssens (Netherlands / IGJ), PIC/S Deputy Chairperson. The full Executive Bureau for the period 2026-2027 consists of:
The PIC/S Committee elected the Members, Deputy Chairs and Chairs of the PIC/S Sub-Committee structure for the period 2026-2027. 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.