The revised Annex 1 on “sterile manufacturing of the PIC/S GMP Guide entered into force on 25 August 2023 and has been published on https://picscheme.org/en/publications. It entered into operation the same day as the revised Annex 1 of the EU GMP Guide, which is identical with PIC/S Annex 1 (with some minor differences). The revised Annex 1 is now applicable with the exception of paragraph 8.123. This paragraph has a later date of entry into force, which is on 25 August 2024. For the background to the revision of Annex 1, see https://picscheme.org/en/news?dateselect=2022
The revised Annex 1 is an integral part of the PIC/S GMP Guide (PE 009-17), which has also been revised. The GMP Guide has 4 parts: Introduction, Part I, Part II, and Annexes. Annex 1 can be found under ‘PIC/S GMP Guide (PE 009-17) Annexes’.
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.