EU promises global cooperation on generics

by Gary Finnegan: The European Medicines Agency (EMA) is to step up international cooperation on regulating generics. The regulator says it is ready to share assessment reports for generic medicines with counterparts outside the EU.

The move is designed to facilitate “timely authorisation and availability of safe, effective and high quality generic medicines worldwide”, according to the Agency.

This will form part of an information-sharing initiative under the International Generic Drug Regulators Pilot (IGDRP). According to the London-based EU medicines watchdog, the EU is leading this initiative in an effort to save resources and to strengthen global scientific assessment systems.

The first phase of the pilot project will involve the EU, Australia, Canada, Chinese Taipei and Switzerland. Other members of the IGDRP may decide to take part in the pilot programme at a later stage. These include Brazil, China, Japan, Korea, Mexico, New Zealand, Russia, Singapore and South Africa.

The European Directorate for the Quality of Medicines & Healthcare (EDQM) and the World Health Organization (WHO) participate in IGDRP as observers.

In the initial phase, 10 applications for generic medicines will be selected for participation in the pilot; further products might be considered after evaluation of first results.