News

January 2022

New PIC/S Executive Bureau

Geneva, 4 January 2022: A new PIC/S Executive Bureau (EB) took office on 1 January 2022. Due to the pandemic, the election of the Executive Bureau was carried out by written procedure and successfully completed on 13 December 2021. The PIC/S Committee unanimously elected Mr Paul Gustafson (Canada / ROEB) as Chairperson for the period 2022-2023. Mr Gustafson will be assisted by Ms Susan Laska (US FDA), PIC/S Deputy Chairperson. The full Executive Bureau for the period 2022-2023 consists of:

  • Mr Paul Gustafson (Canada / ROEB), PIC/S Chairperson;
  • Ms Susan Laska (US FDA), PIC/S Deputy Chairperson and Chair of the Sub-Committee on Strategic Development (SCSD).
  • Ms Anne Hayes (Ireland / HPRA), immediate past PIC/S Chairperson;
  • Mr Jacques Morénas (France / ANSM), Chair of the Sub-Committee on Training (SCT);
  • Dr Andreas Krassnigg (Austria / AGES), Chair of the Sub-Committee on Expert Circles (SCEC);
  • Mr Ger Jan van Ringen (Netherlands / IGJ), Chair of the Sub-Committee on Budget, Risk and Audit (SCB);
  • Mr Ian Jackson (UK / MHRA), Chair of the Sub-Committee on GM(D)P Harmonisation (SCH);
  • Dr Kentaro Hara (Japan / PMDA), Chair of the Sub-Committee on Communication (SC COM); and
  • Mr Henning Willads Petersen (Denmark / DKMA), Chair of the Sub-Committee on Compliance (SCC).
April 2024

JAPAN / PMDA collaboration with PIC/S and WHO

Geneva, 10 April 2024:

At its meetings of May and November 2023, the PIC/S Committee welcomed the announcement made by Japan / PMDA that it would second one PMDA expert to the PIC/S Secretariat in Geneva (Switzerland).

Since 1 April 2024, Dr SUZUKI Hirofumi, PMDA, has been seconded to the PIC/S Secretariat where he is going to serve in order to facilitate PIC/S Secretariat activities including collaboration with the World Health Organization (WHO) with a view to strengthen regulatory capacity building in the Asian region (for more information, see link)

Dr SUZUKI will support the PIC/S Secretariat regarding the harmonisation of GMP standards and the training of inspectors for PIC/S Participating Authorities, especially in Asia. Dr SUZUKI has several years of experience in various PIC/S bodies as well as in participating in PIC/S on-site assessment visits. He will help supporting the operation of PIC/S activities with a focus on Asia.

PMDA has been a Member of PIC/S since 2014. This secondment represents an innovative way by PMDA to support PIC/S and it will help strengthen the PIC/S Secretariat in line with PIC/S’ Strategic Plan (2023-27).

January 2024

6th PIC/S Expert Circle Meeting on Good Distribution Practice (GDP)

Geneva, 30 January 2024:

The Department of Health and the Pharmacy and Poisons Board of Hong Kong (PPBHK) hosted the 6th PIC/S Expert Circle Meeting on Good Distribution Practice (GDP) from 29 November to 1 December 2023 via Zoom. A total of 230 participants joined the meeting. The meeting included discussions on contemporary issues and latest developments in the field of GDP and supply chain integrity; consolidating lessons learnt during COVID to support uninterrupted supply chain of medicine; sharing experiences between inspectors to improve consistency among inspectors in the field of GDP; and exchanging ideas and fostering collaboration among inspectorates. Follow us on LinkedIn.

January 2024

PIC/S-EMA-WHO Joint Implementation Working Group on Revised Annex 1 (manufacture of sterile medicinal products)

Geneva, 23 January 2024:

Friday, 19 January marked the inaugural kickoff meeting of the PIC/S-EMA-WHO Joint Implementation Working Group, bringing together experts from WHO, EMA, and PIC/S Participating Authorities. The goal is to achieve harmonized interpretation of the newly released PIC/S-EU GMP Annex 1 on Sterile Manufacturing. Follow us on LinkedIn.

January 2024

2024 Wishes and Video Message from New PIC/S Chairperson, Mr Jacques Morénas

Geneva, 15 January 2024:

The new PIC/S Chairperson for the period 2024-2025, Mr Jacques Morénas (France / ANSM), is pleased to share with you his 2024 greetings and best wishes in the following video message highlighting key PIC/S priorities and activities for the year coming.

November 2023

PIC/S Committee Meeting and Executive Bureau in Bangkok (Thailand)

The Thailand Food and Drug Administration (Thai FDA), Ministry of Public Health, hosted the following PIC/S events in Bangkok (Thailand) on 6-10 November 2023: PIC/S Committee Meeting, PIC/S Executive Bureau Meeting and PIC/S Annual Seminar.

The PIC/S Committee met on 6-7 November 2023, under the chairmanship of Mr Paul Gustafson (Health Canada). The meeting was attended by 37 out of 56 PIC/S Participating Authorities (PA) as well as by a number of Applicants, Pre-Applicants, and Associated Partner Organisations.