Geneva, 23 September 2026:
The PIC/S GMP Guide to Good Manufacturing Practice (GMP) for Medicinal Products has been revised to include the revised Annex 19 (Reference and Retention Samples).
The revision of PIC/S Annex 19 primarily concerns Section 9, which addresses reference and retention samples for parallel imported, parallel distributed, and parallel traded products. The note clarifying that Section 9 applies only where local legislation covers parallel imported, parallel distributed, or parallel traded products — present in the previous version of the PIC/S GMP Guide (PE 009-17) — has been retained in the current version (PE 009-18).
This update aligns with the Co-operation Agreement between PIC/S and the EMA, which mandates the harmonisation of PIC/S and EU GMP Guides. The aim is to maintain equivalent GMP standards, thereby facilitating the exchange and use of information concerning the manufacture of medicinal products, in line with PIC/S' mission to lead the international development, implementation, and maintenance of harmonised GMP standards and quality systems for inspectorates in the field of medicinal products.
The revised Annex 19 was successfully adopted by the PIC/S Committee by written procedure on 22 September 2026.
The revised GMP Guide (PE 009-18), with the revised Annex 19 will enter into force on 24 September 2026. This coincides with the entry into force of the revised Annex 19 in the EU following the publication by the European Commission of the revised Annex 19 on Eudralex Volume 4 on 23 June 2026.
All non-EEA Participating Authorities of PIC/S and Applicants have been invited to transpose Annex 19 of the PIC/S GMP Guide into their own GMP Guides.
To download the revised GMP Guide (PE 009-18), please consult the “Publications” page.
Geneva, 30 July 2026
PIC/S has published the revised PIC/S Recommendations on Qualification and Validation (PI 006-4).
These Recommendations have been revised by a dedicated PIC/S Working Group, successively chaired by Norman Gray (UK / MHRA) and subsequently jointly chaired by Kevin O’Donnell (Ireland / HPRA) and Rebecca Dowd (USA / US FDA). They supersede the PIC/S Recommendations on Validation Master Plan; Installation and Operational Qualification; Non-Sterile Process Validation; and Cleaning Validation (PI 006-3).
PI 006-4 will enter into force on 1 October 2026.
To download the revised Recommendations document, please consult the page “Publications”.
Geneva, 28 July 2026:
Registrations for the 2026 PIC/S Seminar on “Digital Transformation in GMP” which will be hosted by Türkiye / TMMDA from 4-6 November 2026 are now open (for Medicines Regulatory Authorities only). Deadline for registrations is 31 August 2026 (early-bird) and 23 October 2026 (standard).
For more information, please contact the PIC/S Secretariat.
Geneva, 28 July 2026:
On 15 July 2026, a Rapporteur was appointed by written procedure for the pre-accession application of Emirates Drug Establishment (EDE), for which a pre-accession application was received on 5 March 2026.
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.
Geneva, 28 July 2026:
On 17 December 2025, the State Entity “Center of Good Practices” of the Pharmaceutical Industry Development Agency under the Ministry of Health of the Republic of Uzbekistan and the State Institution “Center for Pharmaceutical Products Safety” under the Ministry of Health of the Republic of Uzbekistan, submitted a joint membership application to PIC/S.
The application received was completed on 15 January 2026, further to which the Rapporteurs and Audit Team are in the process of being appointed by written procedure.
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).