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
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.