Latest News from PIC/S
From 6 to 7 November 2023, the PIC/S Committee Meeting took place in Bangkok, Thailand, chaired by Paul Gustafson from Health Canada. The Ministry of Public Health of the Thai Food and Drug Administration (Thai FDA) hosted the meeting.
The meeting was attended by 37 of the 56 Participating Authorities (PAs) as well as various applicants, pre-applicants and partner organisations.
The most important aspects in brief:
DFA submits application for pre-accession
- The Egyptian Medicines Agency EDA applied for PIC/S pre-accession on 22 September 2023.
- This step involves an assessment by the PIC/S to identify potential discrepancies between the PIC/S membership requirements and the applicant regulatory authority's system. The PIC/S Committee then decides on further steps, e.g. on a possible application for membership.
- The appointment of the rapporteur, who accompanies and supervises the pre-accession process, takes place via a written procedure.
China's NMPA has applied for membership
- On 22 September 2023, China's National Medical Products Administration (NMPA) submitted its application for the PIC/S membership, which was completed on 3 November 2023. The pre-accession procedure was initiated on 24 September 2021.
- The regulatory authority represents all Chinese authorities that participate in the Chinese Good Manufacturing Practice Regulatory Compliance Programme (GMPRCP) of the PIC/S.
- Jacques Morénas from the French authority ANSM has been appointed as rapporteur. He will lead the PIC/S audit team overseeing the accession process.
Memorandum of Understanding with the ICH
- In October 2023, a Memorandum of Understanding (MoU) between the PIC/S and the International Council for Harmonisation (ICH) was signed.
- The MoU aims to ease the cooperation on ICH guidelines of relevance to inspection activities and to provide training for assessors and inspectors.
- As both organisations are active in the field of harmonisation of medicinal products, it is not the first rapprochement. The PIC/S holds observer status with the ICH since 2017, and many ICH regulatory members are themselves PAs with the PIC/S.
A new PIC/S chair for the period 2024-2025 was also elected at the committee meeting in early November. The committee voted unanimously for Mr Jacques Morénas.
Source:
PIC/S: Newsroom
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