Information Sharing for Generics


The Information Sharing Working Group for Generics (IWGG) is a pilot for the sharing of information on the evaluation of Generic Drug applications involving the Decentralised Procedure (DCP) and Centralised Procedure (CP) of the European Union with other IPRP agencies.


An information sharing pilot was launched in July 2014 first as part of the IPRP using the European Union's Decentralised Procedure (DCP) as a model for the sharing of information during the scientific assessment phases of the DCP with IPRP non-EU agencies. Currently, the pilot involves the EU and the regulatory agencies of Health Canada, Swissmedic, Taiwan FDA and Therapeutic Goods Administration. Other members of the IPRP may decide to take part in the pilot at a later stage.


From January 2015 on, the information sharing pilot has been extended to applications for generic medicinal products through the Centralised Procedure (CP). In the initial phase with EU's CP, 10 applications for generic products will be selected for participation to the pilot; further products might be considered after evaluation of the results of the initial phase.


Sharing assessment reports with non-EU regulatory agencies will assist 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 authorised in different territories in a coordinated and timely way.


An outline of the process and information on how to express interest for participation to the information sharing pilots with the EU's Decentralised and centralised Procedures can be found on the right side.


Closure of the project:

In November 2019, the MC reviewed the work conducted by the pilot project of the Information-Sharing WG for Generics for the sharing of information on the evaluation of Generic Drug applications and agreed in view of its completion to propose the closure of the project by the time of the next meeting in May 2020.