News

May 2017

2017 PIC/S Seminar (Chinese Taipei)

Geneva, 15 May 2017: Registrations for the 2017 PIC/S Seminar on "Quality Control Laboratories: How to inspect" (Taipei, 13-15 September 2017) are now open (for National Drug Regulatory Authorities only).

Taiwan Food and Drug Administration, Ministry of Health and Welfare (TFDA) is honoured and proud to announce that the registration is open for the PIC/S Committee Meeting and 2017 PIC/S Seminar hosted by Chinese Taipei / TFDA in Taipei from 11-15 September 2017.

The Seminar, which will take place from 13-15 September, will be on " Quality Control Laboratories: How to Inspect " and consist in a mix of presentations and workshops.

Quality control is part of Good Manufacturing Practice for ensuring the safety, quality and efficacy of pharmaceutical products. Thus, the quality control laboratory plays an integral role in confirming the quality of medicinal products. Through the seminar, participants will be introduced to basic concepts, current and trending regulatory requirements, as well as specific quality issues which have impacted on the regulatory compliance of Quality Control Laboratories. The program will include topics related to GMP inspections on QC lab and will delve into OOS/OOT investigation, data integrity issues and aspects of test methods validation and verification in the context of technical transfer. The seminar will also be a great platform for both novice and experienced inspectors to enhance their inspection skills through knowledge sharing and discussion.

For more information: click here 

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.