E.U. Launches Pilot Project To Speed International Generic Drug Applications

The European Medicines Agency (EMA) announced a new project that will model the E.U.’s decentralized procedure (DCP) for assessing applications for generic medicines. In this new project, a part of the International Generic Drug Regulators Pilot (IGDRP), the DCP will share assessment reports with regulatory agencies outside the E.U.

Only the E.U., Australia, Canada, Chinese Taipei and Switzerland will participate in the first phase of the project. Upon request from a generic pharma company, regulatory agencies will share information with each other and orchestrate the coordinated release of a generic drug in multiple territories at approximately the same time.

If successful, other members of the IGDRP, which include Brazil, China, Japan, Korea, Mexico, New Zealand, Russia, Singapore, South Africa, and the U.S., may choose to participate.

According to the IGDRP, the objective of the pilot project is to “provide for a more efficient and consistent review process while at the same time reducing regulatory burden and facilitating the similar timing of market authorizations across jurisdictions.”

The IGDRP is currently accepting Expressions of Interest (EOI) from pharma companies and will continue to do so through September. Non-E.U. agencies will verify the eligibility of potential products for this project.

According to the EMA, other projects initiated by the IGDRP include work sharing possibilities, inspections of sites conducting bioequivalence studies, and information sharing on pharma quality issues.

The IGDRP, launched in 2012, seeks to meet the needs of an increasingly global world.  Both the WHO and the European Directorate for the Quality of Medicines and Healthcare (EDQM) oversee the progress of the initiative as observers.

According to the World Health Organization (WHO), the initiative seeks to “address challenges posed by increasingly heavy workloads, globalization, and the growing complexity of scientific issues.”