International GMP inspection accord

Australia's Therapeutic Goods Administration, in cooperation with the European Medicines Agency (EMEA) and the US Food and Drug  Administration, has launched a pilot project to rationalize  international Good Manufacturing Practices inspection activities.  Initial planning coordination is underway since November last year, the  TGA stated.

In an effort to improve international sharing of information and to  facilitate more risk-based approaches to inspection planning, the three  regulators have copied the approach of the EMEA, which has a yearly plan  for centralized inspections, while inviting member states of the  European Union to contribute their own plans.

Each regulator is expected to outline the GMP inspections carried out in  the past two to three years, as well as its preliminary timetable for  the next 18 months. This information is pooled to the other authorities  in the cooperation agreement, so they can identify: