EMA to share assessments reports for generic medicines with regulators outside the EU

The European Medicines Agency (EMA) is ready to share its assessments of applications for generic medicines in real time with collaborating regulatory agencies outside the European Union (EU). This initiative aims to facilitate the timely authorisation and availability of safe, effective and high quality generic medicines worldwide.

The information-sharing initiative is part of the International Generic Drug Regulators Pilot (IGDRP). It started in July 2014 using the European Union decentralised procedure as a model, and it is now extended to the centralised procedure.

The EU is leading this initiative with the aim to both save global assessment resources and to facilitate and strengthen the scientific assessment process for medicines. It is expected that this sharing of assessments will allow authorisation of generic products in concerned countries in a coordinated and resource effective way.

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 to 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.

Companies are invited to express their interest in participating in the pilot programme. Further information has been published today on the EMA website.


Posted on the EMA website on 19 January 2015