News

December 2016

Letter of Agreement with the EEA HMA (Heads of Medicines Agencies)

Geneva, 14 December 2016: The Heads of Medicines Agencies is a network of the Heads of the National Competent Authorities whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area. Part of the National Competent Authorities are the (GMP) inspectorates in all different Member States in the European Economic Area. 

PIC/S has a signed letter of agreement with the HMA, which entered into force on 15 August 2016, by which PIC/S and HMA agree to co-operate in exchanging information in the context of the EEA Joint Audit Programme (JAP) of GMP Inspectorates and the PIC/S Joint Reassessment Programme (JRP) of Participating Authorities.

For more information see the website: http://www.hma.eu

To download the letter of agreement (PS/W 18/2016), please consult the page “Publications” or click on the link below:

April 2018

2018 PIC/S Seminar (Chicago, USA)

Geneva, 5 April 2018: Registrations for the 2018 PIC/S Seminar on "Management of Risk through the Product Life-Cycle" (Chicago, 26-28 September 2018) are now open (for National Drug Regulatory Authorities only).

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The United States Food and Drug Administration (US FDA) is proud to announce that registration is now open for the PIC/S Committee Meeting and Seminar, hosted by US FDA from September 24 -28, 2018 in Chicago, Illinois.

The Seminar, entitled "Management of Risk through the Product Life-Cycle," will consist of interactive discussions, presentations, and workshops.

Risk management is critical to ensuring product quality, safety, and efficacy. The Seminar will explore the best practices impacting risk assessments and share tools and techniques generated from experienced inspectors and assessors to enhance inspections. It will be an ideal opportunity for both novice and experienced inspectors to refine their inspection skills through knowledge sharing and discussion.

For more information: click here 

December 2017

Joint targeted stakeholders consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of the PIC/S – EU GMP Guide

Geneva, 20 December 2017: a revision of Annex 1 (Manufacture of Sterile Medicinal Products) of the PIC/S and EU GMP Guides has been prepared in co-operation with the European Medicines Agency (EMA), WHO and PIC/S in order to maintain global alignment of standards, achieving at the same time assurance for the highest quality. The document is subject to parallel public consultation by the European Commission, WHO and PIC/S.

The consultation period will last 3 months and run from 20 December 2017 to 20 March 2018.

Key changes from the earlier Annex 1 are:

  • introduction of new sections: scope, utilities, environmental and process monitoring sections and glossary
  • introduction of the principles of Quality Risk Management (QRM) to allow for the inclusion of new technologies and innovative processes 
  • restructuring to give more logical flow
  • addition of detail to provide further clarity.

In line with the PIC/S-EMA Harmonised Consultation Procedure, comments will be collected by the European Commission (EC). To download the consultation document and the template required to submit comments or for any queries in relation to this public consultation, please refer to the EC website by clicking “here”.

The consultation document is also published on the PIC/S website under the section Drafts on the page “Publications”.

October 2017

Pakistan applies for PIC/S pre-accession

Geneva, 16 October 2017: On 18 September 2017, the Drug Regulatory Authority of Pakistan (DRAP) applied for PIC/S pre-accession. The Rapporteurs will be appointed by written procedure.

October 2017

PIC/S events in Taipei, 11-15 September 2017

Geneva, 12 October 2017: the PIC/S Committee met on 11-12 September 2017 in Taipei (Chinese Taipei). The meeting was followed by the PIC/S annual training Seminar on 13-15 September 2017. The topic of the seminar was "Quality Control Laboratories: How to Inspect".

The press release regarding these events is available in newsletter format here or can be downloaded in pdf format from the link below:

September 2017

Iran / IFDA, Turkey / TMMDA and Mexico / COFEPRIS accede to PIC/S

Taipei, 13 September 2017: At its meeting of 11-12 September 2017 in Taipei (Chinese Taipei), the PIC/S Committee invited Iran's Food and Drug Administration (IFDA), the Turkish Medicines and Medical Devices Agency (TMMDA), and Mexico's Federal Commission for the Protection from Sanitary Risks (COFEPRIS) to join the Scheme from 1 January 2018. Iran / IFDA, Turkey / TMMDA and Mexico / COFEPRIS will become the 50th, 51st and 52nd PIC/S Participating Authorities.