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Deadline postponed for the second targeted consultation on Annex 1
Those who have already submitted their comments are welcome to revise their contribution if they would like to. Only their latest comments will be considered.
The European Commission remain at your disposal in case you would have any further questions at : SANTE-REVISION-OF-ANNEX-1@ec.europa.eu
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Geneva, 20 February 2020:
Period of consultation:
From 20 February 2020 to 20 July 2020.
Objective of the consultation:
Annex 1 was first published in 1971, to ensure sterility of medicinal products placed on the market for the benefits of patients.
Since then it has undergone a number of targeted updates but, until now it has not undergone a full review. This revision is intended to add clarity, introduce the principles of Quality Risk Management to allow for the inclusion of new technologies and innovative processes and to change the structure to a more logical flow. Key changes are:
A first consultation conducted from 20 December 2017 to 20 March 2018 allowed about 140 companies and/or organizations to comment. The joint PIC/S-EMA drafting group (with WHO participation) processed more than 6200 lines of comments.
Due to widespread interest from industry following the first consultation, and because of substantial modifications introduced in several sections, the European Commission (EC), the European Medicines Agency (EMA), WHO and PIC/S have jointly agreed to engage with stakeholders a second targeted consultation on the updated draft guidance (version 12) focused on the sections and/or significantly modified paragraphs that raised most concerns by stakeholders.
The second targeted consultation aims at collecting experience from the sectors on certain manufacturing steps. PIC/S therefore expect to receive contribution from the associations representing the sectors.
Acknowledgment
In order to maintain the global alignment of standards, achieving at the same time assurance for the highest quality, the document will be, in parallel, subject to a second joint targeted consultation by the EC / EMA, WHO and PIC/S.
Joint Consultation Process
In line with the PIC/S-EMA Harmonised Consultation Procedure, comments will be collected by the EC as well as a number of organisations representing relevant stakeholders, which have agreed to receive all the comments of this second consultation from their members, to compile and send the comments to the European Commission. For the list of stakeholders, please refer to the EC website (link provided below), in particular the section on “Targeted Stakeholders”.
To download the consultation document and the template required to submit comments as well as for the process on how to submit comments, please refer to the EC website by clicking “here” - see in particular the section on “How to submit a contribution”.
The consultation document is also published on the PIC/S website under the section Drafts on the page “Publications”
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, 16 June 2025
Registrations for the 2025 PIC/S Seminar on "Advanced Technologies in Pharmaceutical Manufacturing" (Hong Kong, 5-7 November 2025) are now open (for Medicines Regulatory Authorities only).
More
The 2025 PIC/S Annual Seminar on "Advanced Technologies in Pharmaceutical Manufacturing" will be hosted by the Department of Health and the Pharmacy and Poisons Board of Hong Kong (PPBHK) in Hong Kong SAR, China from 5-7 November 2025.
This seminar will focus on the latest development and regulatory considerations of three advancing technologies in pharmaceutical manufacturing:
• Artificial Intelligence (AI)
• Point-of-Care (PoC) Manufacturing
• Continuous Manufacturing
The seminar, starting on the morning of 5 November and ending at about 2pm of 7 November, will consist of presentations and interactive workshops on the above three topics.
For more information, please contact the PIC/S Secretariat.
Geneva, 26 May 2025:
During the PIC/S Committee Meeting held on 14-15 April at IATA Conference Centre in Geneva, we had the great pleasure of welcoming our Special Guests from four African National Regulatory Authorities (NRAs): the Nigeria National Agency for Food and Drug Administration and Control (NAFDAC – Nigeria), the Rwanda Food and Drugs Authority (RFDA – Rwanda), the Tanzania Medicines & Medical Devices Authority (TMDA – Tanzania), and the Senegalese Pharmaceutical Regulatory Agency (ARP – Senegal).
Their visit took place with support from a 3-year grant awarded to PIC/S by the Gates Foundation in May 2024 which aims at strengthening regulatory systems in Africa.
The PIC/S Committee Meeting was a valuable opportunity to meet the representatives of the four NRAs in person and exchange on our respective activities.
During a side-meeting, productive discussions were held about the NRAs’ motivations and the key requirements to initiate the PIC/S Pre-Accession Process. This conversation highlighted the NRAs’ strong commitment to strengthening GMP regulatory systems.
We look forward to a fruitful collaboration in the future!
Geneva, 15 January 2025:
The PIC/S Committee has granted the status of Associated Partner Organisation to the African Union Development Agency - New Partnership for Africa's Development (AUDA-NEPAD).
MoreWith a shared dedication to safeguarding public health and safety, PIC/S and AUDA-NEPAD have decided to establish a cooperation agreement in the field of Good Manufacturing Practice (GMP) standards and quality systems for pharmaceutical products and Active Pharmaceutical Ingredients (API).
The scope of the cooperation agreement includes :
With the active contribution of other stakeholders, collaboration activities will aim at supporting capacity and confidence building among African NRA and at guiding them on their journey toward becoming PIC/S Participating Authorities.
The agreement is also a great opportunity for both partners to develop exchanges of information and share experiences.
This partnership reflects PIC/S commitment to strengthening global harmonization and cooperation in the field of GMP.
We look forward to working closely with our partners and stakeholders to achieve these goals and foster a more robust regulatory environment worldwide.
An official welcome will be given to AUDA-NEPAD at the next PIC/S Committee meeting, which will take place in Geneva on 14 and 15 April 2025.
Geneva, 8 January 2025:
The Department of Health and the Pharmacy and Poisons Board of Hong Kong are pleased to host the 2025 PIC/S Seminar on “Advanced technologies in pharmaceutical manufacturing” in Hong Kong (Hong Kong SAR, China) from 5-7 November 2025, preceded by the PIC/S Committee meeting.
The Seminar is the main annual international training event by PIC/S which is open to GMP Inspectors from PIC/S Participating Authorities, (Pre-)Applicants, Partners and non-PIC/S Member Medicines Regulatory Authorities.