Geneva, 15 June 2021:
Background
EU GMP Annex 16 on Certification by a Qualified Person* and Batch Release entered into force in 2002. At the time, PIC/S did not deem it necessary to transpose this EU-specific annex for PIC/S purposes. Following the revision of EU Annex 16 in 2016, PIC/S re-discussed whether to transpose Annex 16 in order to harmonise internationally requirements regarding product release in line with PIC/S’ mission “to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of Inspectorates in the field of medicinal products”. The PIC/S Sub-Committee on GMDP Harmonisation (SCH), led by Paul Gustafson (Health Canada), was mandated to transpose a PIC/S version of EU GMP Annex 16 in accordance with a memorandum of understanding with the European Medicines Agency (EMA).
* The PIC/S term of “Authorised Person” and the EU term of “Qualified Person” are strictly equivalent.
Public consultation
Following several internal rounds of consultation and extensive discussion between PIC/S Members on draft versions of PIC/S Annex 16, the PIC/S Committee recently agreed to proceed to Step 2 of the PIC/S consultation process. Step 2 of the PIC/S adoption process enables an opportunity for PIC/S Participating Authorities to consult with stakeholders. PIC/S Participating Authorities may take differing approaches to consultation. Some may engage in consultation at later periods through local harmonisation efforts that realize subsequent adaptation of PIC/S GMP into jurisdictional specific GMP guides or requirements.
This consultation will be launched on 15 June 2021 for a period of 3 months. The consultation will focus on national stakeholders of non-EU/EEA Members of PIC/S, considering that EU/EEA Members of PIC/S already apply EU Annex 16.
Where the implementation of PIC/S Annex 16 will affect a jurisdiction, the competent PIC/S Participating Authority will consult pharmaceutical industry associations. This consultation may also be open to the general public and other stakeholders. Comments from stakeholders will be considered carefully while working toward a general objective of ensuring continued harmonisation and equivalence between the EU and PIC/S GMP Guides. Minimal deviations between the guides will help work toward improved global harmonisation.
International professional and industry associations, which are interested to contribute to the PIC/S consultation process, are invited to channel their consolidated comments through one of the PIC/S Participating Authorities, which will launch a public consultation. For further enquiries, please contact info@picscheme.org
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.
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.