The revised Annex 1 to the PIC/S GMP Guide on the manufacture of sterile products has been published and will enter into force on 25 August 2023, except for point 8.123 which is postponed until 25 August 2024. The date of entry into operation is aligned with that of the revised EU Annex 1, which is identical to PIC/S Annex 1 (with some very minor editorial differences).
The entry into force closes a long revision process, which has been driven jointly by PIC/S and the EMA Inspectors’ Working Group (IWG) on GMDP in close co-operation with the European Commission (EC) and the World Health Organization (WHO). This has been a best-in-class model of international co-operation between EC, EMA, WHO, and PIC/S.
Annex 1 was first published in 1971 based on a PIC/S recommendation to ensure the sterility of medicinal products for the benefits of patients. It has undergone a number of partial revisions since its publication. This is, however, the first full revision aiming at restructuring this Annex, adding clarity to the requirements on the sterile manufacturing of medicinal products and introducing the principles of Quality Risk Management to allow for the inclusion of new technologies and innovative processes.
PIC/S decided to establish a Working Group on Annex 1 at its Rome meeting on 15-16 May 2014. It was then merged with the EMA IWG Drafting Group with a view to jointly revise Annex 1. WHO also decided to join the revision process with a view to align Annex 1 to the WHO GMP Guide. The joint Working Group included representatives of the Competent Authorities of PIC/S and EEA as well as WHO. The Working Group was first chaired by Andrew Hopkins (UK / MHRA) and then by Abdelaali Sarakha (France / ANSM).
Following two written consultations of Competent Authorities, the revision of Annex 1 was submitted to joint public consultation in December 2017. Over 6,300 comments were received during the 3-month consultation and then reviewed by the Working Group in 2018-19. This resulted into a new draft of the revised Annex 1, which was submitted to a second joint consultation from February to July 2020, during which approximately 2,000 comments were received and then reviewed by the Working Group in 2020-21.
The revised Annex 1 was then submitted to adoption to the EMA IWG on GMDP and the PIC/S Committee on 1 March and 29 April 2022, respectively. It has then been published by the EC on Eudralex and by PIC/S on the PIC/S website.
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).
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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.
Geneva, 6 January 2025:
It is with great sadness that we share the news of the passing of our esteemed colleague Boon Meow Hoe.
Boon was an emblematic figure of PIC/S for more than 25 years, occupying various positions in our structure, as Chair of course, but also as a member of the Executive Bureau.
He played a key role in the creation of the PIC/S Inspection Academy (PIA), which he continued to support in his role as Chair of the Subcommittee on Training. His imprint on our family is indelible.
Boon's passing is a terrible loss both on a human and professional level and we can only bow before his memory. We will all remember a smiling, courteous, efficient Man, always ready to find solutions. He gave his all for his country but also for us with a vision that was always present to ensure the development and sustainability of PIC/S. He always worked with the same target of ensuring protection of Public Health.
May he rest in peace and live on in our memories, for ever.
Our deepest condolences to his Family and to the Health Sciences Authority of Singapore (HSA).