News

January 2021

Russia applies for PIC/S membership

Geneva, 13 January 2021: On 22 December 2020, the Competent Authorities of the Russian Federation submitted a complete membership application to PIC/S.  The Russian Competent Authorities are:

  • Ministry of Industry and Trade of the Russian Federation (Minpromtorg Russia)
  • Federal Service for Surveillance in Healthcare (Roszdravnadzor), including Federal State Budgetary Institution “Information and Methodological Center for Expertise, Accounting and Analysis of Circulation of Medical Products” (FGBU “IMCEUAOSMP” of Roszdravnadzor)
  • Federal State Institution “State Institute of Drugs and Good Practices” (FSI “SID & GP”)
  • Federal State Budgetary Institution "Scientific Center for Examination of Medical Devices" of the Ministry of Health of the Russian Federation (FSBI ''SCEMD”)

The Rapporteur(s) will be appointed either by written procedure or at the next PIC/S Committee meeting.

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. 

 

November 2023

Co-operation with ICH

Geneva, 29 November 2023:

The PIC/S Committee welcomed at its meeting in Bangkok on 6-7 November 2023 the signature of a Memorandum of Understanding (MoU) between PIC/S and ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) in October 2023...

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Both parties are engaged in pharmaceutical harmonisation activities, PIC/S being an Observer in ICH since 2017 and many Regulatory Members in ICH are also “Participating Authorities” in PIC/S. This MoU is intended to facilitate collaboration on a number of ICH Guidelines that are relevant also for Inspectorate activities and provide training for both assessors and Inspectors.

The MoU lays down the basis for future co-operation between PIC/S and ICH further to the expiry of the ICH pilot on “More Routine Engagement of ICH with PIC/S on ICH Q Guidelines that involve Inspectorates in Implementation”. It provides a framework for co-operation on training efforts, which PIC/S looks forward to strenghtening with ICH.

November 2023

New PIC/S Chairperson and Executive Bureau

Geneva, 20 November 2023:

A new PIC/S Chairperson and Executive Bureau were elected as from 1 January 2024 by the PIC/S Committee at its meeting in Bangkok (Thailand) on 6-7 November 2023.

At this occasion, the PIC/S Committee unanimously elected Mr Jacques Morénas (France / ANSM) as Chairperson for the period 2024-2025. Mr Morénas will be assisted by Ms Kathleen Sinninger (US FDA), PIC/S Deputy Chairperson. The full Executive Bureau for the period 2024-2025 consists of:

  • Mr Jacques Morénas (France / ANSM), PIC/S Chairperson;
  • Ms Kathleen Sinninger (US FDA), PIC/S Deputy Chairperson and Chair of the Sub-Committee on Expert Circles (SCEC);
  • Mr Paul Gustafson (Canada / ROEB), immediate past PIC/S Chairperson;
  • Dr Kentaro Hara (Japan / PMDA), Chair of the Sub-Committee on Communication (SC COM);
  • Mr Henning Willads Petersen (Denmark / DKMA), Chair of the Sub-Committee on Compliance (SCC);
  • Ms Jennifer Burnett (Australia / TGA), Chair of the Sub-Committe on Strategic Development (SCSD);
  • Dr Theresa Mullin (US FDA), Chair of the Sub-Committee on Budget, Risk and Audit (SCB);
  • Mr Boon Meow Hoe (Singapore / HSA), Chair of the Sub-Committee on Training (SCT); and
  • Ms Ying-Hua (Ellen) Chen (Chinese Taipei / TFDA), Chair of the Sub-Committee on GM(D)P Harmonisation (SCH).

The PIC/S Committee elected the Members, Deputy Chairs and Chairs of the PIC/S Sub-Committee structure for the period 2024-2025. Office holders were elected for the following seven Sub-Committees: Training (SCT); Expert Circles (SCEC); Strategic Development (SCSD); Compliance (SCC); GM(D)P Harmonisation (SCH); Budget, Risk and Audit (SCB) and Communication (SC COM). All Sub-Committee Chairs will be Members of the PIC/S Executive Bureau as listed above.

With more than 90 Sub-Committee Members for the period 2024-25, PIC/S has a truly global representation to support diverse perspectives that will help excel on its mission in the interest of public health.

November 2023

China applies for PIC/S membership

Geneva, 20 November 2023:

On 22 September 2023, China’s National Medical Products Administration (NMPA) submitted a membership application to PIC/S, following the successful completion and closure of the PIC/S pre-accession process.

At its meeting in Bangkok on 6-7 November 2023, the PIC/S Committee discussed the membership application received, which was completed on 3 November 2023, and granted the status of Applicant to China / NMPA.

NMPA will be the representative of all Chinese Authorities involved in the Chinese Good Manufacturing Practice Regulatory Compliance Programmes (GMPRCP) as defined by PIC/S.

The Committee appointed Jacques Morénas (France / ANSM) as Rapporteur, who will lead the PIC/S Audit Team which will manage and oversee NMPA’s accession process to PIC/S.

November 2023

Egypt applies for PIC/S pre-accession

Geneva, 20 November 2023:

On 22 September 2023, the Egyptian Drug Authority (EDA) applied for PIC/S pre-accession. The Rapporteur will be appointed by written procedure.