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, 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.
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).