Geneva, 7 July 2025
In light of the rapid advancement of digital technologies and the implementation of AI systems in pharmaceutical manufacturing, the update of Good Manufacturing Practice (GMP) guidelines is essential to ensure that they continue to provide clear, practical and relevant guidance for manufacturers and competent authorities.
The revision of Chapter 4 (Documentation), Annex 11 (Computerized System) and the introduction of the new Annex 22 (Artificial Intelligence) of the PIC/S and EU GMP Guides have been drafted by the Inspectors’ Working Group of the European Medicines Agency (EMA) and PIC/S in order to maintain global alignment of standards, achieving at the same time assurance for the highest quality.
These 3 documents taken together aim at providing a comprehensive and robust framework that supports the implementation of IT technologies in pharmaceutical manufacturing while safeguarding product quality and patient safety.
These documents are subject to a joint stakeholders’ consultation by the European Commission and PIC/S. The consultation period will run for 3 months, from 7 July 2025 to 7 October 2025.
Why to respond to the Joint Consultation
Revision of Chapter 4 - Documentation
The revised Chapter 4 incorporates changes which highlight the importance of documentation in GMP compliance and support the use of new technologies, hybrid solutions, and new services in the management of documentation. Risk-management principles are now central and integrated within the data governance system to ensure the accuracy, integrity, availability, and legibility of documents across all formats—paper, digital, or hybrid. All documentation, whether in text, image, video, or audio form, must remain complete and readable throughout its lifecycle. The guideline also clarifies the requirements for the management of electronic records, signatures, and data integrity while ensuring consistency with the concurrent revision of Annex 11.
Revision of Annex 11 – Computerised Systems
The revised Annex 11 establishes enhanced requirements for the lifecycle management of computerised systems, mandating that Quality Risk Management principles be comprehensively applied during all steps. The updated provisions reinforce obligations concerning the definition and ongoing maintenance of system requirements and the oversight of suppliers and external service providers. Furthermore, the Annex strengthens controls related to the assurance of data integrity, audit trails, electronic signatures, and system security.
New Annex 22 - Artificial Intelligence
The new annex on Artificial Intelligence establishes requirements for the use of AI and machine learning in the manufacturing of active substances and medicinal products. It sets up requirements for the selection, training, and validation of AI models. Emphasis is made on the definition of the intended use of the model, the establishment of performance metrics, the quality of model training data, and the management and processing of test data. Annex 22 foresees a continuous oversight of AI systems, including change control, model performance monitoring and procedures for human review when necessary.
How to respond to the Joint Consultation
If you wish to participate in this targeted consultation and are a member of a stakeholders’ organisation, please contact your organisation to submit your comments.
If you wish to participate and are not a member of a stakeholders’ organisation, comments must be submitted via the EU Survey tool in accordance with the PIC/S-EMA Harmonised Consultation Procedure.
To download the consultation documents and the template required to submit comments or for any queries in relation to this consultation, please refer to the European Commission website by clicking here.
The consultation documents are also published on the PIC/S website under the section Drafts on the page Publications.
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.