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.
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.
Geneva, 30 September 2025:
On 15 August 2025, a Rapporteur was appointed by written procedure for the pre-accession applications of:
In line with the revised PIC/S Guidelines for the Pre-Accession Procedure, the designation of the Rapporteur marks the start of the pre-accession process.