EU, Health Canada Confirm Regulatory Cooperation

On Apr. 2, 2009, the Health Products and Food Branch of Health Canada and European Union (consisting of the European Commission [EC] and European Medicines Agency [EMEA]) released “Implementation Plan for Regulatory Cooperation on Medicinal Products.” The document describes the process of information and document exchange between both organizations as well as the process for monitoring the implementation of the plan. The agreement follows a confidential Exchange of Letters signed by both parties in December 2007.

The implementation plan covers information relating to regulations, legislation under development, draft guidance documents, and nonpublic information about pharmaceuticals and human biologics under review in Canada and the European Union.

According to the implementation plan, EMEA and Health Canada will continue to cooperate in the development of an “exchange and visit program” (exchange of staff members between each organization) as well as an exchange of documents (both “routine” as agreed upon previously and “ad-hoc”).

To implement the plan, a coordination committee will be formed consisting of members from the EC, EMEA, and Health Canada. The committee will conduct annual evaluations and handle “organizational and operational aspects.”