Sixth Meeting of the Joint Sectoral Group (JSG)

of 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 Wednesday December 6, 2023 by video conference, the European Commission (DG SANTE, DG TRADE), European Medicines Agency (EMA), and Health Canada (HC), held the sixth meeting of the Joint Sectoral Group established under 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.

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 was successfully reached this year after the report on the positive equivalence assessment of the 24 EU MS authorities assessed by HC was issued in February 2023.

Both parties are currently working on the internal processes to operationalize the results of the assessment and amend the CETA protocol for pharmaceuticals to include active pharmaceutical ingredients (API).

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

HC has provided an update on the process of the recognition of the EU member states’ NCA. At the current time there are five veterinary and one human products NCA under the assessment process by HC. It was noted that the aim is to recognise all remaining EU NCA.

3. 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 recent proposal for a revision of the basic pharmaceutical legislation.

There were no updates from HC and EMA.