Third Meeting of the Joint Sectoral Group (JSG)

of 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

Report

On Tuesday December 1, 2020 by videoconference, Directorate General of Health and Food Safety (DG SANTE), European Medicines Agency (EMA) and Health Canada (HC) held the third 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 great progress made under this initiative was acknowledged. A comparison of inspection processes conducted by HC, EMA and the European Commission (EC) concluded that Parties have a similar approach for inspections in third countries. The conclusion of the comparative analysis was approved by the co-chairs.

HC and EC also agreed on the respective Certificate of GMP Compliance template that would be exchanged for extra-jurisdictional inspection outcome and to develop a joint communication for stakeholders.

The Parties will inform each other when they are ready to recognise extra-jurisdictional inspections.

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 EC’s audit of HC is planned for the second half of 2021. 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 also in the process of evaluating the API programs of the different EU Member States.

3.  Impact of COVID-19

EU and Canada exchanged on 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.

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 Joint Committee via the CETA Committee on Trade in Goods.