EMA Advances Pilot Program for International Regulatory Cooperation for Generics

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 08-07-2014 14:34


The European Medicines Agency (EMA) reports that the European Union’s (EU) decentralized procedure is being used as a model to accelerate the assessment of applications for generic medicines as part of the International Generic Drug Regulators Pilot (IGDRP).

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.

The EU is part of 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," said the EMA in a statement.

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 and the World Health Organization participate as observers.

This initiative is one of the work packages of the IGDRP. Other areas of cooperation in which the EU is involved include 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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