Geneva, 20 September 2019:
A draft revision of the PIC/S GMP Guide Annex 2 (Manufacture of biological medicinal substances and products for human use) has been prepared by the PIC/S Working Group on revision of Annex 2 established with WHO, led by Francesco Cicirello (Australia / TGA) and by the PIC/S Sub-Committee on GMDP Harmonisation, led by Paul Gustafson (Canada / ROEB).
This revision is subject to a focused stakeholder consultation which includes both consultation questions and an opportunity to comment on:
Draft Annex 2A takes into account the international development in the regulation of Advanced Therapy Medicinal Products (ATMP) with particular attention to the European Commission guideline on GMP for ATMP which has been published since the latest revision of the EU Annex 2, while addressing at the same time concerns of PIC/S Participating Authorities with regard to patient safety and proportionate regulation for ATMPs. Draft Annex 2B is the revised version of EU Annex 2 for biologics (excluding ATMPs).
This consultation will also allow PIC/S to collect feedback from stakeholders to help PIC/S develop its thinking in this area. PIC/S recognises that this is a rapidly developing industry and the revision being developed represents an intention of PIC/S to consider:
- issues that stakeholders including (academia, hospitals, subject matter experts or the pharmaceutical industry SMEs)
are facing in the international context; and
- how harmonised international GMP standards can help to facilitate manufacturing of these products, especially in
consideration of the increasing manufacturing that occur cross-border.
The consultation period will last 3 months and run from 20 September 2019 to 20 December 2019.
To submit feedback, please provide feedback exclusively on the dedicated Consultation Notice (PS/INF 24/2019) and submit in Word format (not PDF) by e-mail with subject line "PIC/S Focused Public Consultation - Revision Annex 2" to one of the following associations which will collect and compile responses. Stakeholders should only reply once.
To download the Consultation Notice (PS/INF 24/2019) and the Draft Annexes 2A and 2B (PS/INF 25/2019 (Rev. 1) and PS/INF 26/2019 (Rev. 1)) please consult the page “Publications” or click on the links below:
PS INF 24 2019 Consultation Notice Revision Annex 2
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.
Geneva, 4 November 2025:
A new PIC/S Chairperson and Executive Bureau were elected as from 1 January 2026 by the PIC/S Committee at its meeting in Hong Kong SAR, China, on 3 November 2025.
At this occasion, the PIC/S Committee unanimously elected Ms Kathleen Sinninger (US FDA) as Chairperson for the period 2026-2027. Ms Sinninger will be assisted by Mr Gwylim Janssens (Netherlands / IGJ), PIC/S Deputy Chairperson. The full Executive Bureau for the period 2026-2027 consists of:
The PIC/S Committee elected the Members, Deputy Chairs and Chairs of the PIC/S Sub-Committee structure for the period 2026-2027. Office holders were elected for the following seven Sub-Committees: Training (SCT); Expert Circles (SCEC); Strategic Development (SCSD); Compliance (SCC); GM(D)P Harmonisation (SCH); Budget, Risk and Audit (SCB) and Communication (SC COM). All Sub-Committee Chairs will be Members of the PIC/S Executive Bureau as listed above.
Geneva, 30 September 2025:
On 15 August 2025, a Rapporteur was appointed by written procedure for the pre-accession applications of:
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, 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”.