EMA Widens Int'l Cooperation in Generics

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 01-19-2015 21:51


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 authorization and availability of generic medicines worldwide.

The information-sharing initiative is part of the International Generic Drug Regulators Pilot (IGDRP). It started in July 2014 using the EU decentralized procedure as a model, and it is now extended to the centralized 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 authorization 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 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(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 program.

The IGDRP was launched in April 2012 to strenghten collaboration and convergence between regulatory agencies worldwide and mitigate challenges of global generic development and approval programs. This information-sharing initiative is one of the work packages of the IGDRP. The EU is also involved in other areas of cooperation which aim to explore work sharing possibilities in the area of active substance master file, inspection of sites conducting bioequivalence and bio-analytical studies, and information sharing on pharmaceutical quality issues.

Source: EMA


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