News

June 2018

Revision of PIC/S GMP Guide (PE 009-14)

Geneva, 20 June 2018: the following Chapters and Annex of the PIC/S GMP Guide have been revised:

  • Chapter 3 on “Premises and Equipment”;
  • Chapter 5 on “Production”;
  • Chapter 8 on “Complaints and Product Recall”;
  • Annex 17 on “Real Time Release Testing and Parametric Release“.

The revised Chapters 3, 5 & 8 of the PIC/S GMP Guide are based on the equivalent Chapters of the EU GMP Guide with some minor differences in terms of language. These Chapters of the PIC/S GMP Guide have now been aligned with principles of Quality Risk Management. Chapter 3 and 5 have been revised to include requirements to prevent cross-contamination. A change in the qualification of suppliers has also been introduced by revised Chapter 5. Expectations with regard to quality management system for the evaluation of quality defects in relation to product recalls have been expanded in Chapter 8, which has been entirely revised. Revised Annex 17 has been aligned with the EU revision of Annex 17 which will be published shortly by the European Commission (EC).

The revision has been successfully completed by the PIC/S Sub-Committee on the Harmonisation of GM(D)P, led by Paul Gustafson (Canada / RORB). The revised GMP Guide (PE 009-14) will enter into force on 1 July 2018. 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 009-14), please consult the page “Publications

June 2024

Zimbabwe applies for PIC/S pre-accession

Geneva, 6 June 2024:

On 20 October 2023, the Medicines Control Authority of Zimbabwe (MCAZ) applied for PIC/S pre-accession. The pre-accession application was considered complete on 6 December 2023. The Rapporteur is in the process of being appointed by written procedure.

April 2024

JAPAN / PMDA collaboration with PIC/S and WHO

Geneva, 10 April 2024:

At its meetings of May and November 2023, the PIC/S Committee welcomed the announcement made by Japan / PMDA that it would second one PMDA expert to the PIC/S Secretariat in Geneva (Switzerland).

Since 1 April 2024, Dr SUZUKI Hirofumi, PMDA, has been seconded to the PIC/S Secretariat where he is going to serve in order to facilitate PIC/S Secretariat activities including collaboration with the World Health Organization (WHO) with a view to strengthen regulatory capacity building in the Asian region (for more information, see link)

Dr SUZUKI will support the PIC/S Secretariat regarding the harmonisation of GMP standards and the training of inspectors for PIC/S Participating Authorities, especially in Asia. Dr SUZUKI has several years of experience in various PIC/S bodies as well as in participating in PIC/S on-site assessment visits. He will help supporting the operation of PIC/S activities with a focus on Asia.

PMDA has been a Member of PIC/S since 2014. This secondment represents an innovative way by PMDA to support PIC/S and it will help strengthen the PIC/S Secretariat in line with PIC/S’ Strategic Plan (2023-27).

January 2024

6th PIC/S Expert Circle Meeting on Good Distribution Practice (GDP)

Geneva, 30 January 2024:

The Department of Health and the Pharmacy and Poisons Board of Hong Kong (PPBHK) hosted the 6th PIC/S Expert Circle Meeting on Good Distribution Practice (GDP) from 29 November to 1 December 2023 via Zoom. A total of 230 participants joined the meeting. The meeting included discussions on contemporary issues and latest developments in the field of GDP and supply chain integrity; consolidating lessons learnt during COVID to support uninterrupted supply chain of medicine; sharing experiences between inspectors to improve consistency among inspectors in the field of GDP; and exchanging ideas and fostering collaboration among inspectorates. Follow us on LinkedIn.

January 2024

PIC/S-EMA-WHO Joint Implementation Working Group on Revised Annex 1 (manufacture of sterile medicinal products)

Geneva, 23 January 2024:

Friday, 19 January marked the inaugural kickoff meeting of the PIC/S-EMA-WHO Joint Implementation Working Group, bringing together experts from WHO, EMA, and PIC/S Participating Authorities. The goal is to achieve harmonized interpretation of the newly released PIC/S-EU GMP Annex 1 on Sterile Manufacturing. Follow us on LinkedIn.

January 2024

2024 Wishes and Video Message from New PIC/S Chairperson, Mr Jacques Morénas

Geneva, 15 January 2024:

The new PIC/S Chairperson for the period 2024-2025, Mr Jacques Morénas (France / ANSM), is pleased to share with you his 2024 greetings and best wishes in the following video message highlighting key PIC/S priorities and activities for the year coming.