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Regulatory Focus™ > News Articles > 11 > EMA, Health Canada to Tighten Alliance Around Mutual GMP Inspections

EMA, Health Canada to Tighten Alliance Around Mutual GMP Inspections

Posted 19 November 2018 | By Zachary Brennan 

EMA, Health Canada to Tighten Alliance Around Mutual GMP Inspections

Though the European Medicines Agency (EMA) and Canada have had a mutual recognition agreement (MRA) in operation since February 2003, both sides announced Monday that they may further strengthen their ties.

On Friday, the European Commission’s DG Sante, EMA and Health Canada held the first Joint Sectoral Group (JSG) on Pharmaceuticals, which is a specialized committee established under the Committee on Trade in Goods of the Comprehensive Economic and Trade Agreement (CETA) protocol.

The JSG “confirmed the possibility of mutual recognition of GMP inspections and batch certification between EU and Canada for medicinal products for human use and veterinary medicines,” according to a note from the EC.

“Six administrative arrangements to facilitate the effective implementation and to monitoring the CETA Protocol were approved in principle and should be adopted before the end of the year. Possible extensions of the scope to include GMP inspections of active substance manufacturers and inspection conducted in third countries were also discussed.”

The agreement will allow EMA and Health Canada to make better use of their inspection resources by reducing duplicate inspections in each other’s territory by reducing administrative burdens and costs for the pharmaceutical sector, the EC announced.

EMA also has MRAs with Australia, Israel, Japan (which recently expanded), New Zealand, Switzerland and the US.

In March 2017, the EU and US mutually recognized one another’s pharmaceutical manufacturing inspections – a deal also likely to lead to less duplicative inspections and lower costs on both sides of the Atlantic.

New step in the Comprehensive Economic and Trade Agreement (CETA) between EU and Canada

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