Geneva, 6 October 2020:
Registrations for the 2020 PIC/S Seminar on "Distant Assessment of GMP Compliance" which will be hosted virtually from 8-10 December 2020 are now open (for Medicines Regulatory Authorities only). Deadline for registration is 8 November 2020.
For more information, please contact the PIC/S Secretariat.
The Finnish Medicines Agency (FIMEA) is hosting on-line the 2020 PIC/S Seminar on “Distant Assessment of GMP Compliance" on 8-10 December 2020.
This Seminar on Distant Assessment of GMP Compliance places special emphasis on real-time interactive assessment using ITC (Information Technology and Communication) tools. Distant assessment in the context of the Seminar is an interchangeable term with remote or virtual inspections.
The Seminar programme contains presentations and discussions on the implementation of distant GMP assessment/inspection activities in different jurisdictions and on information security in virtual real-time communications. We also look to share the experiences of Inspectors involved in off-site GMP assessment/inspections as well as those inspected.
The Seminar is open to the participation of Inspectors from Medicines Regulatory Authorities around the world.
For more information, please contact the PIC/S Secretariat.
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.
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.