Fourth 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 November 18, 2021 by videoconference, Health Canada (HC) and Global Affairs Canada (GAC), European Medicines Agency (EMA), and Directorate General of Health and Food Safety (DG SANTE), held the fourth meeting of the JSG on Pharmaceuticals under CETA.

Discussion topics included:

1. CETA Regulatory Cooperation Forum (RCF): recognition of third countries drug facility inspections conducted by each party.

The objective of this initiative is the recognition of inspections conducted in countries outside of the respective Parties’ jurisdictions (i.e. extra-jurisdictional inspections) for products included in the operational scope of Annex 1 of the CETA Protocol on Pharmaceuticals.

The project was successfully concluded in April 2021. The competent authorities of both parties agreed on the recognition of the other party’s extra-jurisdictional inspection outcome and on the corresponding Certificate of GMP Compliance template that would be exchanged.

Canada and the EU recognized the collaborative effort that resulted in this positive achievement.

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

The evaluation is ongoing to determine whether the regulatory framework applicable to API and related enforcement activities are equivalent. The European Commission’s audit of HC was initially planned for 2021 but was postponed to June 2022 because of the pandemic travel restrictions. Although the EU’s evaluation will be done in the framework of article 111b of Directive 2001/83/EC, outside of the CETA, the conclusion of the equivalence of HC reached within this framework will be taken over in the CETA.

HC is progressing in the process of evaluating the API programs of the different EU Member States and preliminary conclusions and considerations have already been exchanged by both parties.

3. Impact of COVID-19

EU and Canada exchanged on the current situation with respect to GMP inspections where onsite inspections are resuming and virtual/remote or  hybrid inspection  are  options to further explore.

Both parties are also considering the future of the temporary regulatory and operational flexibilities put in place to ensure continued access to essential and safe health products in the context of the COVID-19 pandemic and agreed that a harmonised post-pandemic approach between strategic partners should be favoured.

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.