IGDRP: Information Sharing Pilot extended to the authorisation of generics under the EMA's Centralised Procedure

23.01.2015

At the last meeting of the International Generic Drug Regulators Programme (IGDRP), which took place in Singapore on 4 and 5 November 2014, the EU offered to extend the Information Sharing Pilot to the EMA's Centralised Procedure. Upon synchronised submission of an application for authorisation of a generic product (for Swissmedic, a "medicinal product with a known active substance without innovation") to the EMA and an authority taking part in the pilot, the EMA will share the assessments in real time with the collaborating authorities.


Participation in the pilot is subject to the same requirements and preconditions as participation in the Information Sharing Pilot for the EU's Decentralised Procedure (see Swissmedic announcement of 31 July 2014 at)

Swissmedic participates in this pilot as part of its international activities and as an active member of the IGDRP since its foundation. If you are interested in taking part, please complete the corresponding forms and submit them no later than 31 March 2015.


Completed forms should be sent to the EMA (IGDRPpilot@ema.europa.eu) and Swissmedic (networking@swissmedic.ch) at least 8 weeks prior to the intended submission.


Further information can be found in the document Information Package Centralised Procedure and on the EMA website at