Geneva, 10 August 2016: PIC/S has published on a draft basis a guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1 (Draft 2)) developed by the PIC/S Working Group on Data Integrity. This draft guidance will be applied on a 6-month trial basis by PIC/S Participating Authorities. This draft document results from the need among Inspectorates to have access to harmonised Data Integrity guidance, considering the impact to public health. The purpose of the trial-period is to learn from implementation. It is acknowledged that the guidance requires expanding in some areas; however, the document has value in describing foundational principles which can be enhanced in future revisions. This draft document is not open for comments by industry. Formal adoption of the guidance will proceed in accordance with PIC/S procedures - including possibly an industry consultation - on a revised version after completion of the trial-period.
To download the draft guidance (PI 041-1 (Draft 2)), please consult the page “Publications” or click on the link below:
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.