Regulatory Update

Posted 01 October 2011 | By Michael Matthews

The use of foreign reviews in Health Canada has always been considered, but has only happened on an ad hoc basis and has not been consistent. On 9 September 2011, Health Canada released draft guidance for consultation for the use of foreign reviews in marketing applications. The guidance clarifies for applicants the way Health Canada will use foreign reviews for marketing authorization. Nonetheless, a Canadian marketing application must still contain all of the necessary information and materials normally submitted.

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