EMA and FDA GCP initiative a success
Main objective of the cooperation was sharing information on inspections
The European Medicines Agency (EMA) and the US Food & Drug Administration have concluded that their cooperation under a Good Clinical Practice (GCP) initiative since September 2009 has been a success. Its main objective was sharing information on inspections and GCP-related documents of common interest and staging collaborative inspections.
A joint report concluded that the pilot initiative has been ‘very productive’ and a ‘considerable amount of information has been exchanged, and this communication has facilitated improvements in the agencies’ inspection coverage and decision-making processes’.
Both organisations want to continue and intensify cooperation, carrying out more joint inspections ‘to identify the gaps in each agency’s inspection processes and to fill in those gaps’.
The aim of the scheme is ‘mutual acceptance of inspectional findings in the near future’, which could reduce the workload of both agencies.
Expanded cooperation would involve staging inspections at sites outside the EU or the US.
A similar EMA pilot with Australia’s Therapeutic Goods Administration has also been successful.