News

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.

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

Saudi Arabia applies for PIC/S pre-accession

Geneva, 7 August 2017: On 31 July 2017, Saudi Arabia’s Saudi Food and Drug Authority (SFDA) 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.

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).

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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 

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:

March 2017

PIC/S events in Geneva, Switzerland, 8-10 February 2017

Geneva, 7 March 2017: the PIC/S Committee met on 9-10 February 2017 in Geneva (Switzerland), preceded by a meeting of the PIC/S Executive Bureau on 8-9 February 2017.

The press release regarding these meetings can be viewed here.