News

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.

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.

August 2023

Entry into force of revised GMP Annex 1

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’.

August 2023

Philippines applies for PIC/S membership

Geneva, 7 August 2023: On 20 June 2023, Philippines Food and Drug Administration (FDA PH) submitted a complete membership application to PIC/S. 

The Rapporteur(s) will be appointed by written procedure.

August 2023

PIC/S Seminar 2023

Geneva, 2 August 2023: Registrations for the 2023 PIC/S Seminar on “Soft Skills that Make a Good GMP/GDP Inspector in 2023” which will be hosted by Thai FDA from 8-10 November 2023 are now open (for Medicines Regulatory Authorities only). Deadline for registration is 31 October 2023.

For more information,  please contact the PIC/S Secretariat.

June 2023

Bulgaria / BDA and Saudi Arabia / SFDA join PIC/S

Geneva, 12 June 2023:  The PIC/S Committee has invited Bulgaria’s Bulgarian Drug Agency (BDA) and Saudi Arabia’s Saudi Food and Drug Authority (SFDA) to join the PIC Scheme.

Bulgaria / BDA will become PIC/S’ 55th Participating Authority and Saudi Arabia / SFDA PIC/S 56th Participating Authority as from 1 July 2023.

BDA submitted a complete membership application in August 2018. The PIC/S assessment was combined with a Canadian MRA assessment and EMA JAP audit. A paper assessment was carried out followed by a joint tripartite PIC/S – EMA - Canada MRA on-site assessment visit which took place in February 2023, after establishment of the new system for the GMP Inspectorate of BDA [following a JAP audit in 2018]. The assessment report was finalised in April 2023. The Audit team recommended to the Committee to accept the PIC/S membership application of BDA, which was endorsed by the PIC/S Sub-Committee on Compliance (SCC). At its meeting in Geneva on 11-12 May 2023, the PIC/S Committee then unanimously accepted the membership of BDA in PIC/S as from 1 July 2023.

SFDA submitted a complete membership application in February 2020, after successfully completing the pre-accession process. This facilitated the accession process. A paper assessment was carried out followed by an on-site assessment visit which took place in March 2023. The assessment report was finalised in the course of April 2023. The Audit team recommended to the Committee to accept the PIC/S membership application of SFDA, which was endorsed by the PIC/S Sub-Committee on Compliance (SCC). At its meeting in Geneva on 11-12 May 2023, the PIC/S Committee then unanimously accepted the membership of SFDA in PIC/S as from 1 July 2023.

June 2023

Changes to the PIC/S Executive Bureau

Geneva, 12 June 2023: A new PIC/S Deputy Chairperson and a new PIC/S Sub-Committee on Strategic Development (SCSD) Chair took office on 11 May 2023. Due to the retirement from her Agency of the former PIC/S Deputy Chairperson and SCSD Chairperson, Susan Laska (US FDA), the PIC/S Committee carried out by-elections at its last meeting in Geneva on 11-12 May 2023. It unanimously elected Mr Jacques Morénas (France / ANSM) as new PIC/S Deputy Chairperson - in addition to his current position of PIC/S Sub-Committee on Training (SCT) Chair - and elected Ms Jennifer Burnett (Australia / TGA) as new PIC/S Sub-Committee on Strategic Development (SCSD) Chair. All other Executive Bureau Members remain the same.

With these changes, the new composition of the Executive Bureau for the remaining of the period 2022-2023 consists of:

  • Mr Paul Gustafson (Canada / ROEB), PIC/S Chairperson;
  • Mr Jacques Morénas (France / ANSM), PIC/S Deputy Chairperson and Chair of the Sub-Committee on Training (SCT);
  • Ms Anne Hayes (Ireland / HPRA), immediate past PIC/S Chairperson;
  • Dr Andreas Krassnigg (Austria / AGES), Chair of the Sub-Committee on Expert Circles (SCEC);
  • Mr Ger Jan van Ringen (Netherlands / IGJ), Chair of the Sub-Committee on Budget, Risk and Audit (SCB);
  • Mr Ian Jackson (UK / MHRA), Chair of the Sub-Committee on GM(D)P Harmonisation (SCH);
  • 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); and
  • Ms Jennifer Burnett (Australia / TGA), Chair of the Sub-Committee on Strategic Development (SCSD).
January 2023

Adoption and Entry into force of New GDP Guidance Documents

PIC/S has published the following two guidance documents for GDP inspectors: an ‘Aide-Memoire on the Inspection of Good Distribution Practice for Medicinal Products in the Supply Chain’ (PI 044-1) and a ‘Questions & Answers (Q&A) document regarding the PIC/S GDP Guide’ (PS/INF 22/2017). These documents have been prepared by the PIC/S Expert Circle on GDP, led by Karen Ford (South Africa / SAHPRA), and will enter into force on 1 February 2023. They are available for downloading on the page “Publications”.