Geneva, 3 September 2025:
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 update of Chapter 1 on Pharmaceutical Quality System of the Good Manufacturing Practice (GMP) guidelines is necessary to establish efficient regulatory frameworks based on good science and risk management.
This revision aligns GMP requirements with international best practices and adapts them to industry advancements, ensuring both the availability and the quality of medicines.
The update of Chapter 1 of the PIC/S and EU GMP Guides has been prepared by the Inspectors’ Working Group of the European Medicines Agency (EMA) and PIC/S in order to maintain global alignment of standards.
This document is subject to a joint stakeholders’ consultation by the European Commission and PIC/S. The consultation period will run for 3 months, from 3 September 2025 to 3 December 2025.
Why to respond to the Joint Consultation
The revised Chapter 1 - Pharmaceutical Quality System incorporates changes which reflect the updated ICH guideline on Quality Risk Management, ICH Q9(R1), strengthening knowledge management and risk management across the product lifecycle.
Alignment with ICH Q9(R1) fosters a proactive, evidence-based culture that reduces variability in quality outcomes. By embedding risk-based decision-making and emphasising scientific rationale and proportionality in risk assessment, it ensures consistent product quality and availability.
The revision also stresses the importance of proactive identification of manufacturing risks to prevent shortages and mitigate supply chain vulnerabilities, thereby safeguarding patient safety and public health.
The guideline also clarifies requirements for product quality review, particularly regarding product grouping and situations where only a limited number of batches were manufactured during the review period.
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 document 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 document is also published on the PIC/S website under the section Drafts on the page “Publications”.
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).