News about GMP/cGMP

23.11.2018

EU and Health Canada plan to include GMP inspections on APIs in MRA

The Comprehensive Economic and Trade Agreement (CETA) between the EU and Canada also includes the CETA GMP Protocol. In continuation of the MRA of 2003 between the EC and Health Canada this protocol also confirmed the continued mutual recognition of GMP inspections and batch certification between EU and Canada for medicinal products for human use and veterinary medicines.

In a first conference of the Joint Sectoral Group (JSG, a specialized committee established under the Committee on Trade in Goods of CETA protocol) on pharmaceuticals, further arrangements were discussed. Possible extensions of the scope would be to include GMP inspections of active substance manufacturers and inspections conducted in third countries.

Following a recently expanded MRA with Japan and a MRA with the US FDA, this would be another move to make better use of inspection resources by reducing duplicate inspections in each other’s territory and eventually in third countries.