News

August 2016

Draft PIC/S Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments

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 This draft guidance will be applied on a 6-month trial basis by PIC/S Participating Authorities.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To download the draft guidance (PI 041-1 (Draft 2)), please consult the page “Publications” or click on the link below:

April 2021

Revision of PIC/S GMP Guide (PE 009-15)

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: Manufacture of Advanced Therapy Medicinal Products for Human Use (ATMP); and
  • Annex 2B: Manufacture of Biological Medicinal Substances and Products for Human Use

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

January 2021

Jordan applies for PIC/S membership

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.

January 2021

Revision of PIC/S Aide Memoires (PI 009-4; 024-3; 028-2; 038-2)

Geneva, 19 January 2021: the following PIC/S guidance documents have been revised:

  • PI 009-4 Aide Memoire on Utilities
  • PI 024-3 Aide Memoires on Biotech
  • PI 028-2 Aide Memoire on Packaging
  • PI 038-2 Aide Memoire on Assessment of QRM Implementation

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

January 2021

Russia applies for PIC/S membership

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:

  • Ministry of Industry and Trade of the Russian Federation (Minpromtorg Russia)
  • Federal Service for Surveillance in Healthcare (Roszdravnadzor), including Federal State Budgetary Institution “Information and Methodological Center for Expertise, Accounting and Analysis of Circulation of Medical Products” (FGBU “IMCEUAOSMP” of Roszdravnadzor)
  • Federal State Institution “State Institute of Drugs and Good Practices” (FSI “SID & GP”)
  • Federal State Budgetary Institution "Scientific Center for Examination of Medical Devices" of the Ministry of Health of the Russian Federation (FSBI ''SCEMD”)

The Rapporteur(s) will be appointed either by written procedure or at the next PIC/S Committee meeting.

November 2020

Brazil / ANVISA joins PIC/S

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.