News

September 2022

Publication of revised PIC/S Annex 1

The revised Annex 1 to the PIC/S GMP Guide on the manufacture of sterile products has been published and will enter into force on 25 August 2023, except for point 8.123 which is postponed until 25 August 2024. The date of entry into operation is aligned with that of the revised EU Annex 1, which is identical to PIC/S Annex 1 (with some very minor editorial differences).

The entry into force closes a long revision process, which has been driven jointly by PIC/S and the EMA Inspectors’ Working Group (IWG) on GMDP in close co-operation with the European Commission (EC) and the World Health Organization (WHO). This has been a best-in-class model of international co-operation between EC, EMA, WHO, and PIC/S.

Annex 1 was first published in 1971 based on a PIC/S recommendation to ensure the sterility of medicinal products for the benefits of patients. It has undergone a number of partial revisions since its publication. This is, however, the first full revision aiming at restructuring this Annex, adding clarity to the requirements on the sterile manufacturing of medicinal products and introducing the principles of Quality Risk Management to allow for the inclusion of new technologies and innovative processes.

PIC/S decided to establish a Working Group on Annex 1 at its Rome meeting on 15-16 May 2014. It was then merged with the EMA IWG Drafting Group with a view to jointly revise Annex 1. WHO also decided to join the revision process with a view to align Annex 1 to the WHO GMP Guide. The joint Working Group included representatives of the Competent Authorities of PIC/S and EEA as well as WHO. The Working Group was first chaired by Andrew Hopkins (UK / MHRA) and then by Abdelaali Sarakha (France / ANSM).

Following two written consultations of Competent Authorities, the revision of Annex 1 was submitted to joint public consultation in December 2017. Over 6,300 comments were received during the 3-month consultation and then reviewed by the Working Group in 2018-19. This resulted into a new draft of the revised Annex 1, which was submitted to a second joint consultation from February to July 2020, during which approximately 2,000 comments were received and then reviewed by the Working Group in 2020-21.

The revised Annex 1 was then submitted to adoption to the EMA IWG on GMDP and the PIC/S Committee on 1 March and 29 April 2022, respectively. It has then been published by the EC on Eudralex and by PIC/S on the PIC/S website.

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.