Geneva, 25 March 2022:
PIC/S is a non-binding, informal co-operative arrangement among Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It has the legal status of an Association under the Swiss law. PIC/S presently comprises 54 Members, which includes the State Service of Ukraine on Medicines and Drugs Control (SMDC).
Given the ongoing tragic events in Ukraine, PIC/S wishes to express its sympathy with all those affected by the war, in particular the most vulnerable: the wounded and the sick. More than ever, patients, whether civilian or military, must be granted indiscriminate access to medicines and medical treatment, irrespective of the circumstances.
As any organisation around the world, PIC/S stands by its Members. PIC/S appeals for a peaceful resolution to the crisis to enable all its Members to continue their important work in protecting patient safety, including the inspection of medicinal products. Violence against staff of any PIC/S Member, who are working to ensure the access of patients to medicine, is unacceptable.
Peaceful co-operation among Regulatory Authorities is at the very heart of PIC/S. PIC/S wishes to reaffirm that as a technical, non-political organisation, it is more important than ever to promote co-operation between Regulatory Authorities in the field of public health. PIC/S is not an agreement among States. While waiting for peace to return to Europe, PIC/S will continue to work untiringly to protect patient safety.
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).
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.
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.
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.
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.