Health Canada & EMA Expands GMP Mutual Recognition Agreement to Include Extra-Jurisdictional Inspections

On 1 April 2021, Health Canada (HC) communicated the scope for the mutual recognition agreement (MRA), between Canada and the EMA, has been widened to include GMP inspections conducted outside of HC and EMA jurisdictions. This is dependent upon the presentation of a Certificate of GMP compliance (CoC), valid in the region and period issued by the EMA.
Subject matter experts are of the opinion that this update will benefit Gilead Canada (GSCI) as it shortens the time required to prepare a drug establishment license (DEL) application across regions.
As per the assessment conducted by RA Canada (see attachment below for details), the updated MRA allows for the maintenance or addition of foreign buildings to GSCI’s DEL, providing that the most recent GMP inspection is conducted by HC or equivalent EU Regulatory Authority.
This updated agreement is likely to facilitate heightened cooperation and regulatory alignment between HC and the EMA. This latest guidance replaces the Canada-EU 1998 MRA Annex issued in September 2017, under the Comprehensive Economic and Trade Agreement (CETA).

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