USFDA Commissioner, Dr. Margaret Hamburg, calls for closer and more global cooperation on GMP at PIC/S' 40th Anniversary
The Pharmaceutical Inspection Co-operation
Scheme (PIC/S) celebrated its 40th anniversary
at a landmark symposium in Geneva
(Switzerland) on 31 May 2011. PIC/S is a
technical arrangement between 39 Competent
Authorities in the field of GMP inspections of
pharmaceutical manufacturing sites. The
symposium was opened by PIC/S Chairman,
Mr. Tor Gråberg (Sweden / MPA), who
underlined the need for PIC/S to further
promote co-operation based on communication,
mutual trust and harmonisation.
Over 160 participants from all continents participated in the event, including Competent
Authorities from Argentina, Australia, Brazil, China, Chinese Taipei, Croatia, most EU/EEA
Member States, Georgia, Hong Kong SAR, Indonesia, Iran, Israel, Japan, Malaysia, New
Zealand, Nigeria, Russia, Singapore, Saudi Arabia, South Africa, South Korea, Switzerland,
Thailand, Turkey, Uganda, Ukraine, and USA. The long list demonstrates that the
organisation, created by 10 European Authorities back in 1971, has now become truly global.
PIC/S co-operates with the European Commission and has partnership agreements with the
European Medicines Agency (EMA), EDQM, UNICEF and WHO; it also co-operates with
non-profit organisations like ISPE and PDA and industry associations such as APIC, EFPIA,
IFPMA, in the field of training.
The 40th Anniversary symposium coincided with the first-time attendance of the Ukrainian
State Inspectorate for Quality Control of Medicines (SIQCM) and the US Food and Drug
Administration (FDA) as full Members of the Organisation. US FDA Commissioner,
Dr. Margaret Hamburg, delivered a key note address to the symposium and called upon all
Regulatory Authorities to co-operate more closely and share information on GMP inspections,
in particular in third countries. PIC/S' main advantage over a Mutual Recognition Agreement
is that it is not legally binding, thus allowing Participating Authorities to co-operate and share
information informally (subject to confidentiality) while keeping complete control over
imported medicinal products. For more information on PIC/S' 40th Anniversary, see
www.picscheme.org.