News

October 2022

PIC/S 50th Anniversary

Geneva, 14 October 2022: 

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) celebrated its 50th anniversary at a special symposium in Dublin (Ireland) on 4 October 2022. Since the first meeting of the PIC Committee in 1972, PIC/S has come a long way! The symposium titled “Thriving at 50 and Striving Forward” aimed at promoting and highlighting PIC/S’ contributions to international collaboration and co-operation while being resolutely turned towards the future.

The symposium was opened by Ireland’s Health Products Regulatory Authority (HPRA) Chief Executive, Ms Lorraine Nolan, who was hosting. The PIC/S Chairperson, Mr Paul Gustafson (Health Canada) presented on PIC/S new strategic plan for 2023-2027 while the PIC/S Deputy Chairperson, Ms Susan Laska (US FDA), outlined the evolution of pharma industry and PIC/S. The keynote speaker, Ms. Emer Cooke, Executive Director of the European Medicines Agency (EMA), addressed how to strive for better international relationships and collaboration. The programme comprised a wide range of presentations and panel discussions on inspection-related topics, which included participation from Heads of Medicines Agencies, Heads of GMDP Inspectorates and official PIC/S representatives.

Close to 200 participants from all continents participated in the event, including most of PIC/S 54 Participating Authorities and 7 (Pre-)Applicant Authorities, PIC/S Associated Partner Organisations (European Commission, EDQM, EMA, UNICEF, WHO and WOAH) as well as a number of non-PIC/S Competent Authorities. The anniversary also provided a unique opportunity to meet and engage with a range of invited stakeholders present for the occasion and to reconnect with the wider PIC/S network. A more detailed press release will follow covering also PIC/S meetings and 2022 Annual Training Seminar, which took place in Dublin back-to-back with the anniversary symposium.

> To the new PIC/S Strategic Plan (2023-2027)

> To the Anniversary Programme

> To the Anniversary Group Photo

> To the Anniversary Promotional Video

January 2025

The African Union Development Agency - New Partnership for Africa's Development (AUDA-NEPAD) becomes a new PIC/S Associated Partner Organisation

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).

More

With 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 :

  • Facilitating pre-accession and accession processes to PIC/S for National Regulatory Authorities (NRA) members of the African Medicines Agency (AMA);
  • Training of inspectors in the field of GMP;
  • Participating at each other’s meetings.

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.

January 2025

2025 PIC/S Seminar in Hong Kong (SAR)

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.

January 2025

Passing of Mr Boon Meow Hoe, PIC/S Executive Bureau member (Singapore / HSA)

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).

December 2024

Adoption and Entry into force of Guidance Documents on Remote Assessments

Geneva, 13 December 2024: 

PIC/S has published the following two guidance documents for inspectors: "Guidance on Remote Assessments" (PI 056-1) and "Aide Memoire on Remote Assessments" (PI 057-1). These documents have been prepared by the PIC/S Working Group on Remote Assessment, led by Jenny Hantzinikolas (Australia / TGA), and will enter into force on 1 January 2025. They are available for downloading on the page "Publications".

November 2024

Strengthening regulatory inspection standards to facilitate improved access to quality medicines in Africa

Geneva, 20 November 2024: 

PIC/S is pleased to announce that in May 2024 it has been awarded a 3-year grant from the Bill & Melinda Gates Foundation.

More

This funding will provide PIC/S with the necessary resources to further its mission to improve public health by leading development and implementation of inspection frameworks for human and veterinary medicines through harmonisation of standards and offering world class training to regulatory inspectors around the globe.

The PIC/S project workstreams supported by this grant will aim at strengthening regulatory inspection standards to facilitate improved access to quality medicines in African countries by preparing a number of African National Regulatory Authorities for entry into PIC/S - through the PIC/S pre-accession process - as well as foster exchanges and co-operation between PIC/S, the upcoming African Medicines Agency (AMA) and its related members.

PIC/S looks forward to the possibilities that this grant will bring and to the impact it will have globally thanks to the support of the Bill & Melinda Gates Foundation.