EMA to share assessment reports about generic drugs with other regulators
Aims to improve collaboration worldwide and address challenge of assessing generic drug applications
The European Medicines Agency (EMA) is ready to begin sharing its assessments of generic drugs with regulatory agencies outside the European Union (EU).
The initiative is part of the International Generic Drug Regulators Pilot (IGDRP) and aims to improve collaboration with regulators worldwide and address the challenge of assessing generic drug applications.
The EU also hopes to save resources and strengthen the scientific assessment process for medicines. It is expected that this sharing of assessments will allow authorisation of generic products in a coordinated and resource-effective way.
The first phase of the pilot project will involve representation from the EU, Australia, Canada, Chinese Taipei and Switzerland.
Other members of the IGDRP, including Brazil, China, Japan, Korea, Mexico, New Zealand, Russia, Singapore and South Africa, may take part in the pilot programme at a later stage.
The European Directorate for the Quality of Medicines & Healthcare (EDQM) and the World Health Organization (WHO) participate in the IGDRP as observers.
Initially, 10 applications for generic medicines will be selected to take part 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.
