Geneva, 2 August 2021: Registrations for the 2021 PIC/S Seminar on "GMP Assessment Approaches in Post COVID-19 Era" which will be hosted virtually from 9-11 November 2021 are now open (for Medicines Regulatory Authorities only). Deadline for registration is 3 October 2021.
For more information, please contact the PIC/S Secretariat.
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The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea is pleased to announce that the 2021 PIC/S Virtual Seminar will be hosted by MFDS from 9 to 11 November 2021.
The Seminar on “GMP Assessment Approaches in Post COVID-19 Era” will consist of presentations, interactive panel discussions, and workshops for GMP Inspectors from around the world.
As the COVID-19 pandemic has put restrictions on GMP on-site inspections, various alternative GMP assessment approaches have been taken by Regulatory Authorities to ensure the quality of pharmaceuticals. As we face the post COVID-19 era, there is a need to explore the current and future status of these GMP assessment approaches. There is also a need to be prepared for the changes that will likely be seen in post COVID-19. Therefore, in this Seminar, we look forward to valuable presentations and discussions regarding different experiences in distant assessment from regulatory and industry experts; and regarding the status of GMP assessment based on reliance.
The Seminar is open to the participation of Inspectors from Medicines Regulatory Authorities around the world.
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’.
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.
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.
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.
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: