Geneva, 12 June 2023:
The PIC/S Committee has invited Bulgaria’s Bulgarian Drug Agency (BDA) and Saudi Arabia’s Saudi Food and Drug Authority (SFDA) to join the PIC Scheme.
Bulgaria / BDA will become PIC/S’ 55th Participating Authority and Saudi Arabia / SFDA PIC/S 56th Participating Authority as from 1 July 2023.
BDA submitted a complete membership application in August 2018. The PIC/S assessment was combined with a Canadian MRA assessment and EMA JAP audit. A paper assessment was carried out followed by a joint tripartite PIC/S – EMA - Canada MRA on-site assessment visit which took place in February 2023, after establishment of the new system for the GMP Inspectorate of BDA [following a JAP audit in 2018]. The assessment report was finalised in April 2023. The Audit team recommended to the Committee to accept the PIC/S membership application of BDA, which was endorsed by the PIC/S Sub-Committee on Compliance (SCC). At its meeting in Geneva on 11-12 May 2023, the PIC/S Committee then unanimously accepted the membership of BDA in PIC/S as from 1 July 2023.
SFDA submitted a complete membership application in February 2020, after successfully completing the pre-accession process. This facilitated the accession process. A paper assessment was carried out followed by an on-site assessment visit which took place in March 2023. The assessment report was finalised in the course of April 2023. The Audit team recommended to the Committee to accept the PIC/S membership application of SFDA, which was endorsed by the PIC/S Sub-Committee on Compliance (SCC). At its meeting in Geneva on 11-12 May 2023, the PIC/S Committee then unanimously accepted the membership of SFDA in PIC/S as from 1 July 2023.
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).