Geneva, 1 July 2021: PIC/S is pleased to announce that following adoption by the Committee on 1 June 2021, the PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1) will enter into force on 1 July 2021. The document marks the completion of significant effort by PIC/S Participating Authorities over an extended period of collaboration to address an area of significant industry and regulatory interest. The guidance has been developed primarily for Inspectors, but also serves as a valuable resource for industry to provide clarity on areas of greatest risk and regulatory expectations. The PIC/S Working Group on Data Integrity acknowledges the support from professional associations across the pharmaceutical industry who contributed to a targeted stakeholder engagement exercise in 2019. The feedback received was highly valuable in identifying opportunities to further clarify regulatory interpretations and also collate topics for future revisions.
The draft guidance was first published by PIC/S in 2016 and applied by PIC/S Participating Authorities on a trial basis. Based on Members’ comments, it was revised by the Working Group on Data Integrity and then subject to a focused stakeholder consultation on specific issues (November 2018 - March 2019). The Working Group incorporated the feedback from stakeholders and submitted the final draft to the PIC/S Committee for adoption.
The Working Group continues its data integrity activities through development of training material for the PIC/S Inspectorates’ Academy (PIA) and other inspection-related resources for Inspectors within the network.
To download this guidance (PI 041-1), please consult the page “Publications”.
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.
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...
MoreBoth 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.
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:
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.
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.
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.