News

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”.

March 2019

Bangladesh applies for PIC/S pre-accession

Geneva, 5 March 2019: On 26 February 2019, Bangladesh's Directorate General of Drug Administration (DGDA) applied for PIC/S pre-accession. The Rapporteurs will be appointed at the next PIC/S Committee meeting in Geneva (Switzerland) on 9-10 April 2019.

November 2018

Focused stakeholders consultation on revised draft PIC/S guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments

Geneva, 30 November 2018: a revised Draft PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1 (Draft 3)) has been prepared by the PIC/S Working Group on Data Integrity, co-led by Australia / TGA and UK / MHRA.

The purpose of the guidance is to serve to outline the position an inspector would adopt during the inspection of GDP/GMP facilities and is designed to facilitate a harmonised approach to the inspection, including reporting in regards to data management and integrity. A first draft (PI 041-1 (Draft 2)) was published by PIC/S on a trial basis in August 2016. Following feedback received from PIC/S Participating Authorities during its 6-month implementation trial-period, the draft of this guidance has been updated and expanded by the Working Group.

The document (PI 041-1 (Draft 3)) is subject to a focused stakeholder consultation seeking substantive comments from trade and professional associations on specific questions relating to the proportionality, clarity and implementation of the guidance requirements. In parallel to this stakeholder consultation, the new draft will be applied by PIC/S Participating Authorities on a trial basis for a new implementation trial period.

The consultation period will last 3 months and run from 30 November 2018 to 28 February 2019.

To submit feedback, please provide feedback exclusively on the dedicated template available on the websites of the below associations and submit by e-mail with subject line "PIC/S Focused Public Consultation – Data Management and Integrity" to one of the following associations which will collect and compile responses. Stakeholders should only reply once.

To download the consultation document (PI 041-1 (Draft 3)) please consult the page “Publications” or click on the link below:

October 2018

PIC/S events in Chicago, United States, 24-28 September 2018

Geneva, 31 October 2018: the PIC/S Committee met on 24-25 September 2018 in Chicago, Illinois (USA). The meeting was followed by the PIC/S annual training Seminar on 26-28 September 2018. The topic of the seminar was "Management of Risk Through the Product Life-Cycle".

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

August 2018

Bulgaria applies for PIC/S membership

Geneva, 27 August 2018: On 27 August 2018, the Bulgarian Drug Agency (BDA) applied for PIC/S membership. The Rapporteurs will be appointed at the next PIC/S Committee meeting in Chicago (USA) on 24-25 September 2018.

August 2018

Jordan applies for PIC/S pre-accession

Geneva, 13 August 2018: On 9 August 2018, the Jordan Food & Drug Administration (JFDA) applied for PIC/S pre-accession. The Rapporteurs will be appointed at the next PIC/S Committee meeting in Chicago (USA) on 24-25 September 2018.