News

April 2017

PIC/S reaffirms its stance on proposed EU ATMP GMP Guidelines and highlights gaps relating to patient safety

Geneva, 25 April 2017: On 24 April 2017, PIC/S sent a letter in response to a reply received from the European Commission on 5 April 2017 in connection with PIC/S' stance on the proposed EU Advanced Therapy Medicinal Products (ATMP) GMP Guidelines, which will not only lower GMP standards for ATMP at the risk of patients but also lead to an internationally non harmonised approach to the implementation of GMP for ATMP.

In its latest letter, PIC/S reaffirms its position and highlights gaps relating to patient safety, while welcoming the Commission's proposal for engagement with PIC/S on its initiative and seeking clarification on the scope of co-operation proposed.

For reasons of transparency and rights of patients, this letter has been published via the link below:

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.

August 2017

Russia applies for PIC/S pre-accession

Geneva, 28 August 2017: On 28 August 2017, the Ministry of Industry and Trade of the Russian Federation (Minpromtorg Russia), in charge of domestic GMP inspections, jointly with the Federal State Institution “State Institute of Drugs and Good Practices” (FSI “SID & GP”), in charge of foreign GMP inspections, applied for PIC/S pre-accession. The Rapporteurs will be appointed at the next PIC/S Committee meeting in Taipei (Chinese Taipei) on 11-12 September 2017.