Seventh meeting of the Joint Sectoral Group (JSG)

Report on the Protocol to the Canada-EU Comprehensive Economic and Trade Agreement between the European Union (EU) and Canada on the Mutual Recognition of the Compliance and Enforcement Programs regarding Good Manufacturing Practices (GMP) for Pharmaceutical Products.

Report

On Monday February 17, 2025 by video conference, the European Commission (DG SANTE, DG TRADE), European Medicines Agency (EMA), and Health Canada (HC), held the seventh meeting of the Joint Sectoral Group established under the Protocol to the Canada-EU Comprehensive Economic and Trade Agreement (CETA) between the European Union (EU) and Canada on the mutual recognition of the Compliance and Enforcement Programs regarding Good Manufacturing Practices (GMP) for pharmaceutical products.

Discussions topics included:

1. Extension of the operational scope of the CETA protocol for pharmaceuticals to include active pharmaceutical ingredients (API).

The determination of equivalence of respective GMP compliance programs for active pharmaceutical ingredients (APIs) was successfully reached and concluded in 2023. At the time of the sixth JSG meeting, Canadian and European parties were following their respective internal processes to pursue the operationalization of these assessments and amend the CETA protocol for pharmaceuticals to include APIs. There has been on-going efforts in both jurisdictions to find a way forward to amend the treaty in the context of the current provisional application of the underlying treaty. 

2. State of play of the recognition of EU national competent authorities (NCA) by Health Canada.

HC provided an update on the process of the recognition of the EU member states’ NCA. Since the sixth JSG meeting, HC initiated evaluations of three NCAs; one with oversight of human pharmaceutical products and two with oversight of veterinary products.  These HC assessments are in-progress.  This leaves three remaining NCAs, with oversight of veterinary products, for evaluation by HC. 

3. Administrative Arrangement (AA)

HC and EU colleagues identified the need to update Article 15.3 (c) List of Contact Points AA under of the CETA protocol.  They agreed to work together to effect necessary revisions to ensure up to date information regarding contact points for all listed parties.

4. Updates from Health Canada, the European Medicines Agency and the European Commission

The Commission provided an update on the recent developments regarding the Pharmaceutical Strategy for Europe and the revision of the pharmaceutical legislation.

There were no updates from HC and EMA.