Information Sharing Pilots with European Union's Decentralised and Centralised Procedures

Updates on the Information and work sharing projects group

As part of the IGDRP, an information sharing pilot was launched in July 2014 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 IGDRP 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 IGDRP 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 here:

PDF iconInternational Generic Drug Regulators Programme (IGDRP) Information Sharing Pilot.pdf

PDF iconExpression Of Interest (EOI)_Request_Form to Participate in the Fisrt Information Sharing Pilot for the Evaluation of Generic Drug Applications involving the Decentralised Procedure of the European Union (First Expresion of Interest to participate in an Information Sharing pilot).pdf

FileExpression of Interest (EOI) Request to participate in the Information Sharing Pilot for the Evaluation of Generic Drug Applications involving the Centralised Procedure of the European Union.docx

FileSummary of Quality Differences.docx

Questions & Answers on IGDRP (January 2015)

Generic medicinal product applications through EU’s Decentralised Prodedure

Generic medicinal product applications through EU’s Centralised Procedure