04.05.2015 - The application deadline for participation in the information-sharing pilot project has been extended for generic medicines under the centralised procedure of the European Medicines Agency (EMA).
The EMA has launched this project in January 2015 as part of the International Generic Drug Regulators Pilot (IGDRP) programme. If an application for generic medicines (i.e. a "medicinal product with a known active pharmaceutical ingredient without innovation") is submitted simultaneously to the EMA and a regulatory agency participating in the pilot, the EMA will make the evaluation reports available to this regulatory agency in real time.
Interested applicants may still apply to participate in this pilot and may send the relevant documents to both the EMA (IGDRPpilot@ema.europa.eu) and Swissmedic (networking@swissmedic.ch) no later than eight weeks before submission of the application. Relevant documents may be found under "Supplementary information".