Fifth 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 Thursday December 15, 2022, by videoconference, Health Canada (HC), Global Affairs Canada (GAC), European Medicines Agency (EMA), and the Directorate General of Health and Food Safety (DG SANTE), held the fifth meeting of the Joint Sectoral Group (JSG) on Pharmaceuticals under Canada-European Union Comprehensive Economic and Trade Agreement (CETA).
Discussion topics included:

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

The evaluation is nearing conclusion to determine whether the regulatory framework applicable to API and related enforcement activities are equivalent. The European Commission (EC)’s audit of HC took place in June 2022 and resulted in a determination of equivalence. HC’s listing as a third country by the EC is expected to be published in January 2023.

HC is finalizing its evaluation of the API programs of the different EU Member States, in response to which conclusions and considerations have been exchanged by both parties. HC plans to finalise the evaluation report in February 2023.

Both parties are currently looking into options available to operationalize the results of the assessment until an amendment to the CETA protocol for pharmaceuticals can be made.

2. Discussion on further collaborative work and recognition

HC shared the work currently underway in this space, taking into consideration recent events, the pandemic, and how experience is reflected in future approaches. For example, HC has embraced the opportunity to elevate inspection reliance to the next level.

The EC shared that discussions are underway in the EU with respect to the future and greater inspection reliance is front of mind. Changes to the legislative framework are underway to introduce the concept of inspection reliance and a system of regulatory oversight that includes remote and hybrid inspections.

Endorsement by the chairs was received to continue discussions and share information on this topic.

3. Impact of COVID-19

EU and Canada exchanged on the current situation with respect to flexibilities put in place to ensure continued access to essential and safe health products in the context of the COVID-19 pandemic. While these flexibilities were in response to the COVID-19 pandemic, both parties are considering if any of these flexibilities can be incorporated into post-pandemic operations and continue to apply.

The DG SANTE, EMA and HC agreed to the importance of continued progress on the topics discussed above.

The results of the meeting will be reported to the CETA Committee on Trade in Goods.