Europe Leads Generic-Drugs Assessment Project

The European Union, in an aim to reinforce collaboration and information sharing between regulatory agencies throughout the world, is participating in the International Generic Drug Regulations Pilot (IGDRP) project. The EU’s decentralized procedure will be used by international regulatory agencies as a model for facilitating generic-drug application assessments.

The EU, at the request of a generic-drug company, will share assessment reports in real time with collaborating international regulatory agencies. According to a European Medicines Agency press release, this sharing of information will contribute to facilitating and strengthening the scientific assessment process, enabling drugs to be authorized in different territories in a coordinated fashion at approximately the same time.

The first phase of the pilot project will involve the EU, Australia, Canada, Chinese Taipei and Switzerland. Other members of the IGDRP (e.g., Brazil, China, Japan, Korea, Mexico, New Zealand, Russia, Singapore and South Africa) may decide to take part in the pilot program at a later stage. The European Directorate for the Quality of Medicines & Healthcare (EDQM) and the World Health Organization will observe the project.