International collaboration to continue

Two pilot programmes of collaboration between the EMA, the FDA and Australia’s TGA have been deemed a success.

The International API Inspection Pilot Programme and the Good Clinical Practice Initiative focused on joint working to improve drug quality and safety across the globe.

The EMA says the alliance provides the “foundation for a more efficient use of limited resources, improved inspectional coverage and better understanding agency's inspection procedures”.

The trio have now agreed to continue the collaboration agreement and learn from the past experiences encountered during the piloting stage.

The International API Inspection Pilot Programme began between the three organisations in December 2008 and ran for two years. The Pilot EMA/FDA Good Clinical Practice (GCP) Initiative ran from September 2009 to March this year.

During the GCP pilot the EMA and FDA exchanged more than 250 document relating to 54 different medicines and organised 13 collaborative inspections of clinical trials.

Over the course of the 24-month API programme, the participants shared surveillance lists and found 97 sites common to all three regions, resulting in the exchange of almost 100 reports relating to 9 joint inspections.