EU-PIC/S GMP Annex 3 Revision Concept Paper Released

PIC/S Publications & Updates

Published December 16th, 2025

Detected March 13th, 2026

Summary

The EMA and PIC/S have released a concept paper proposing revisions to Annex 3 of the EU-PIC/S GMP Guide concerning the manufacture of radiopharmaceuticals. This consultation period runs until February 15, 2026, and aims to update guidance to reflect current practices and innovative approaches.

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What changed

The European Medicines Agency (EMA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) have issued a concept paper outlining proposed revisions to Annex 3 of the EU-PIC/S Good Manufacturing Practice (GMP) Guide, specifically addressing the manufacture of radiopharmaceuticals. This revision aims to update the existing guidance, which was last issued in 2008, to cover areas not previously addressed, clarify existing sections, and support advancements in pharmaceutical manufacturing and control. The concept paper is open for public consultation from December 15, 2025, to February 15, 2026.

Regulated entities, particularly drug manufacturers and pharmaceutical companies involved in radiopharmaceuticals, should review the proposed changes and consider submitting comments by the February 15, 2026 deadline. This consultation is a crucial step in shaping the updated GMP requirements for radiopharmaceuticals, and active participation can influence the final guidance. Failure to comply with future updated Annex 3 requirements could lead to regulatory scrutiny and potential enforcement actions.

What to do next

Review the concept paper on the revision of EU-PIC/S GMP Annex 3.
Submit comments via the EU Survey tool by February 15, 2026.
Prepare for potential updates to radiopharmaceutical manufacturing practices based on the revised Annex 3.

Source document (simplified)

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Concept Paper on the Revision of EU-PIC/S GMP Annex 3 (Radiopharmaceuticals)

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.

February 2026

Concept paper on the revision of EU-PIC/S GMP Annex 6 - Manufacture of medicinal gases

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.

February 2026

Concept paper on the revision of EU-PIC/S GMP Annex 15 (Qualification and validation)

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.

February 2026

Kazakhstan applies for PIC/S membership

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.

February 2026

Ghana applies for PIC/S pre-accession

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.

January 2026

Jordan / JFDA joins PIC/S

Geneva, 1 January 2026:

On 1 January 2026, the Jordan Food & Drug Administration (JFDA) became the 57 th 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.