Regulatory Focus™ > News Articles > PIC/S Elects New Chairman, Adds Croatia’s HALMED as Participating Authority

PIC/S Elects New Chairman, Adds Croatia’s HALMED as Participating Authority

Posted 25 November 2015 | By Zachary Brennan 

PIC/S Elects New Chairman, Adds Croatia’s HALMED as Participating Authority

The Pharmaceutical Inspection Cooperation Scheme (PIC/S) has elected Paul Hargreaves of the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) as its new chairman for 2016 and 2017.

Hargreaves, elected at a meeting in Indonesia last month, will be the fourth PIC/S chairman from the UK and he will follow the departure of Joey Gouws, acting head of South Africa’s Medicines Control Council, who was the first PIC/S chairperson from Africa.  

Following the successful implementation of the new PIC/S sub-committee structure in 2014, office holders were also elected for the following seven sub-committees: Training (SCT); Expert Circles (SCEC); Strategic Development (SCSD); Compliance (SCC); GM(D)P Harmonisation (SCH); Budget, Risk and Audit (SCB) and Communication (SC COM).

All continents are represented by the 52 newly appointed office holders, and 29 are from non-European PIC/S participating authorities.

Croatia

In addition to the new chairman, PIC/S invited the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) to join the scheme from 1 January 2016. HALMED will become PIC/S’ 48th participating authority and the agency previously applied for membership on 5 September 2014.

The regulator was accepted into the scheme after a paper assessment was conducted, followed by an on-site visit from 29 June to 3 July 2015.

Six other regulators have applied to participate in PIC/S, including Brazil’s ANVISA, Iran’s Ministry of Health (on-site visit conducted in September), Mexico’s COFEPRIS (on-site visit planned for 2016), Thailand’s FDA, Philippines’ PFDA and Turkey’s TMMDA.

In addition, an update on prospective future applicants was given at the meeting in October, particularly in regards to exchanges with China’s Food and Drug Administration on their interest in applying to PIC/S in the near future.

Regulators from Belarus, Chile and Kazakhstan are also in the pre-application phase of joining the scheme.

PIC/S November Update


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