LONDON — The European Union is leading an international pilot project through which, upon request from a generic pharmaceutical company, it will share the assessment reports generated as part of the decentralized procedure in real time with collaborating regulatory agencies outside the EU.
By offering to share its assessment reports, the EU aims to reinforce collaboration and information-sharing between regulatory authorities across the world, contributing to facilitating and strengthening the scientific assessment process for medicines. This should enable medicines to be authorized in different territories in a coordinated way at approximately the same time.
The first phase of the International Generic Drug Regulators 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 program 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 and the World Health Organization participate as observers.
The IGDRP was launched in April 2012 to promote collaboration and convergence in generic medicines regulatory programs in order to address the challenges posed by increasing workloads, globalization and complexity of scientific issues.