FDA becomes official member of PIC/S

At its last meeting in Malaysia on 8-9 November 2010, the PIC/S Committee officially invited the US-American health authority FDA (Food and Drug Administration) and the Ukrainian authority SIQCM to join the Pharmaceutical Inspection Co-operation Scheme as from 1 January 2011 (see the press release). PIC/S will then have 38 members.

The process of admission to PIC/S took some time. The US-American authority applied for membership back in September 2005. After audits performed by PIC/S in the USA in 2009 and 2010 the audit team recommended to the Committee to accept the membership application.

The Ukrainian authority applied even earlier for membership - already in April 2004. Currently, there are eleven other applications for membership, including applications from the Taiwan Food and Drug Administration and the Brazilian authority ANVISA.

The Pharmaceutical Inspection Co-Operation Scheme (PIC/S) offers to pharmaceutical authorities a platform for an active and constructive co-operation in the field of GMP.

The purpose is the international development, implementation and maintenance of harmonised Good Manufacturing Practice (GMP) standards and of the quality assurance systems of regulatory authorities in the pharmaceutical sector.

This aim is to be achieved with the:

  • Development and support of harmonised GMP standards and guidelines 
  • Training of authorities, especially of inspectors
  • Assessment (and reassessment) of the regulatory authorities 
  • Facilitation of co-operation 
  • Networking between the relevant authorities and international organisations

In contrast to a MRA (Mutual Recognition Agreement), however, membership does not automatically imply a reciprocal recognition of inspection reports.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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