Geneva, 25 June 2015: ICH has published the ICH Q7 Questions & Answers on Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. PIC/S contributed to this Q&A document which provides interpretation to GMP for APIs since the implementation of the ICH Q7 Guideline.
The ICH Q7 Guideline is originally based on a PIC/S draft guideline on API and was adopted by PIC/S in 2001, then integrated as part II of the PIC/S GMP Guide in 2007.
The ICH Q&A document can be downloaded from the link below:
Geneva, 23 April 2021: The PIC/S GMP Guide to Good Manufacturing Practice (GMP) for Medicinal Products has been revised to include a new Annex 2A and 2B:
Annex 2A provides PIC/S GMP requirements for ATMP - it is not a standalone document but it enables reasonable harmonisation with the standalone ATMP Guidelines published by the European Commission. Annex 2B had very minor revisions and continues to harmonise with the EU Annex 2 for human use biological medicinal substances and products.
The revision has been successfully completed by the PIC/S Sub-Committee on the Harmonisation of GM(D)P, led by Paul Gustafson (Canada / ROEB), based on the work of the PIC/S Working Group on Annex 2. This Working Group was led by Francesco Cicirello (formerly with Australia / TGA) until May 2020 and then by Christina Meissner (Austria / AGES), who finalised the revision.
The revised GMP Guide (PE 009-15), with the new Annex 2A and 2B, will enter into force on 1 May 2021. All non-EEA Participating Authorities of PIC/S and Applicants have been invited to transpose the revised Chapters of the PIC/S GMP Guide into their own GMP Guides.
To download the revised GMP Guide (PE 009-15), please consult the page “Publications”
Geneva, 26 January 2021: On 20 January 2020, Jordan Food & Drug Adminstration (JFDA) submitted a complete membership application to PIC/S.
The Rapporteur(s) will be appointed either by written procedure or at the next PIC/S Committee meeting.
Geneva, 19 January 2021: the following PIC/S guidance documents have been revised:
The revision process consisted in updating the cross-references to the PIC/S GMP Guide. No other changes were made. The revised Aide Memoires enter into force on 1 January 2021.
To download the revised Aide-Memoires, please consult the page “Publications”
Geneva, 13 January 2021: On 22 December 2020, the Competent Authorities of the Russian Federation submitted a complete membership application to PIC/S. The Russian Competent Authorities are:
The Rapporteur(s) will be appointed either by written procedure or at the next PIC/S Committee meeting.
Geneva, 30 November 2020 : The PIC/S Committee has invited Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) to join the PIC Scheme.
Brazil / ANVISA will become PIC/S’ 54th Participating Authority as from 1 January 2021. ANVISA submitted a complete membership application in October 2014. A paper assessment was carried out followed by an on-site assessment visit which took place in October 2019, after a reorganisation at ANVISA. The assessment report was finalised in the course of 2020. The Audit team recommended to the Committee to accept the PIC/S membership application of ANVISA. After endorsement by the PIC/S Sub-Committee on Compliance (SCC), the PIC/S Committee then unanimously decided by written procedure completed on 27 November 2020, on the participation of ANVISA in PIC/S.
This is the first time in PIC/S’ history that an assessment process is completed by written procedure rather than at a Committee meeting. This was due to the situation with Covid-19 which prevented a Committee meeting taking place in 2020. A special welcome will be given to ANVISA at the next PIC/S virtual Committee meeting in 2021.