The past decade has seen numerous drugs come “off patent” and a consequent increase in the number of generic products seeking approval.

In April 2012 the International Generic Drug Regulators Programme (IGDRP) instigated a pilot programme for the shared evaluation of generic applications. The European Decentralised Procedure (DCP) was used as the model for data sharing. This pilot scheme allowed for the sharing of information, during the scientific assessment, with IGDRP competent authorities external to the European Union (EU) including Australia, Canada, Chinese Tapei and Switzerland.

The main reasons for adopting a shared evaluation process was to improve efficacy of the process; enable better use of human resource in the regulatory agencies via enhance information sharing and to adopt a risk based approach.

Initially the evaluations were restricted to decentralised files in the EU; in January 2015 this was extended to include EU Centralised files. The requirements for involvement in this extended pilot scheme includes several caveats including synchronized filing in at least one of the IGDRP participating jurisdictions and no significant differences between products in the various jurisdictions. Overall this initiative should enable a more expedient approval in multiple jurisdictions.

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