September 2022

The European Commission (DG SANTE) becomes a new PIC/S Associated Partner Organisation

Geneva, 29 September 2022: The PIC/S Committee has granted the status of Associated Partner Organisation to the European Commission’s Directorate-General for Health and Food Safety (DG SANTE).

Recognising that they share a common goal to protect public and animal Health and Safety, PIC/S and DG SANTE have agreed to enter into a working arrangement to co-operate in areas of common interest. The co-operation will notably be on Good Manufacturing and Distribution Practice (GMDP) standards and their implementation processes for medicinal products for human or veterinary use with a view to make best use of available resources and avoid duplication of activities. DG SANTE has very close relations and interactions as part of the EU Regulatory Network with the European Medicines Agency (EMA), which has its own co-operation agreement with PIC/S. Also the Heads of Medicines Agencies of the European Economic Area (HMA) have signed a letter of agreement with PIC/S in 2016. The co-operation between PIC/S and DG SANTE under this new arrangement will be complementary to those co-operations.

This new bilateral co-operation arrangement will lead to opportunities for increased international co-operation and is very much in line with similar agreements that PIC/S has signed with other associated partners such as EMA, EDQM, UNICEF, WOAH and WHO. Along with this new co-operation arrangement, a new trilateral working arrangement on the exchange of non-public information between PIC/S, EC and EMA has also been signed.

An official welcome will be given to DG SANTE at the next PIC/S Committee meeting in Dublin (Ireland) on 3 October 2022.

June 2024

Zimbabwe applies for PIC/S pre-accession

Geneva, 6 June 2024:

On 20 October 2023, the Medicines Control Authority of Zimbabwe (MCAZ) applied for PIC/S pre-accession. The pre-accession application was considered complete on 6 December 2023. The Rapporteur is in the process of being appointed by written procedure.

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.