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 

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.