Geneva (22 June 2010): Recently, PIC/S has been invited by the European Commission to participate in an initiative for enhanced international co-operation in the field of APIs. PIC/S believes that the proposal is a recognition of its important role in the field of APIs, in particular with regard to: 

• the assessment of Competent Authorities;
• training (through the PIC/S Expert Circle on APIs) and;
• sharing of information related to APIs inspections.

On 22 June 2010, the PIC/S Chairman sent a positive response to the Commission regarding PIC/S’ involvement.

In relation with the Commission’s proposal, the PIC/S Expert Circle on APIs has started developing, in co-operation with other partners (e.g. EDQM, EMA, ICH, US FDA, WHO, etc.), an international training for inspectors on APIs.  The training will focus on i) an introduction to ICH Q7 (basic course) and ii) on how to inspect APIs (advanced course).

Geneva (19-20 May 2010): At its last meeting, the PIC/S Committee decided that PIC/S’ 40th anniversary will be celebrated in Geneva on 31 May 2011 and will include a discussion forum on “40 years of co-operation: prospects for the future”

Taipei City (14 June 2010): The complete application file for PIC/S membership was received from Taiwan’s Food and Drug Administration (TFDA).

With the application of TFDA, four Asian Competent Authorities are currently assessed for joining PIC/S. Other Asian applications are expected, soon. Recently, the Health Department of Hong Kong also announced its intention to apply for PIC/S membership, in the near future (see news below). According to PIC/S rules, several Competent Authorities from the same country can apply for membership.

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Surray (7 June 2010): United Kingdom's Veterinary Medicines Directorate (VMD) lodged a complete application file for PIC/S membership

After the accession to PIC/S of the Czech Institute for State Control of Veterinary Biologicals and Medicines (ISCVBM) in 2005 and the French Agency for Veterinary Medicinal Products (ANMV) in 2009, UK's VMD is the third veterinary authority to apply for PIC/S membership.

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Wellington (16 April 2010): New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) has officially submitted its application for PIC/S membership. 

Geneva (19-20 May 2010): A delegation form US FDA participated in the last meeting of the PIC/S Committee meeting.

Following discussions with the delegation the Committee decided to send a reduced audit team for a follow-up visit to the USA from 9 to 13 August 2010 in order to review the outstanding issues in the assessment of US FDA’s application for PIC/S membership.

Geneva (20 May 2010): The PIC/S Committee has endorsed a Memorandum of Understanding (MoU) between PIC/S and the Russian Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor) with a view to encourage the latter’s application for PIC/S membership.

Geneva (18 May 2010): In the margin of the Committee meeting, the PIC/S Chairman together with several Executive Bureau Members met with a Delegation from Hong Kong SAR led by Dr. P. Y. Lam, Director of Hong Kong’s Department of Health.  The meeting focused on the Department of Health’s intention to submit an application for PIC/S membership.

Geneva (19-20 May 2010) The 31st meeting of the PIC/S Committee took place in Geneva (Switzerland) on 19-20 May 2010.

The meeting was preceded by a meeting of the PIC/S Executive Bureau on 17 May and a meeting of the Sub-Committee on Training on 18 May. 

To read the press release, click on the link below.