Report: Eighth 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 Tuesday May 26, 2026 by video conference, the European Commission (DG SANTE and DG TRADE), the European Medicines Agency (EMA), Health Canada (HC) and Global Affairs Canada, held the eighth 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.

1. Inclusion of active pharmaceutical ingredients (API) in the operational scope of the CETA protocol for pharmaceuticals

The determination of equivalence of the respective GMP compliance programmes for active pharmaceutical ingredients (APIs) was successfully concluded in 2023. On that basis, in February 2026, the EU and Canada agreed on the draft text of the CETA Joint Committee decision that will add APIs to the operational scope of the CETA GMP Protocol.

The Parties agreed to adopt the CETA Joint Committee decision by written procedure and expect the amendment to the CETA GMP Protocol to be finalised soon. Stakeholders on both sides will receive tangible benefits from the amended CETA GMP Protocol, as the Parties will now mutually recognise their compliance certificates and inspections of APIs. This will reduce costs for manufacturers and free up the capacity of EU and Canadian authorities, allowing them to focus on inspections of higher-risk manufacturers in other countries.

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 seventh JSG meeting, Health Canada has made significant progress in advancing the evaluation of the remaining EU NCAs. HC has evaluated three NCAs, which are now recognised by HC as equivalent to HC’s GMP compliance programme. It remains a priority for HC to evaluate the remaining three authorities in the EU.

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

Health Canada provided an update on the Government of Canada’s Red Tape Reduction Review, which focuses on streamlining regulations to reduce administrative burden and making regulatory processes more efficient and easier to navigate, while maintaining high standards of protection for health and safety. The objective is to make regulatory requirements more modern, risk-based, and responsive to today’s environment. Health Canada’s Drug Establishment Licence Modernisation initiative is being advanced with the purpose of updating Health Canada’s licensing framework so that it is more flexible, more risk-based and better suited to the current global context.

The Commission provided an update on the revision of the EU pharmaceutical legislation, the main objectives of which are to guarantee the safety, efficacy and quality of medicines, while also supporting simplification and competitiveness, and improving access to, availability of and affordability of medicines. New measures related to decentralised manufacturing of medicines; the system of supervision and inspections of the NCAs; joint inspections; the joint audit programme between competent authorities; the establishment of an EMA inspectorate; and provisions on international cooperation in inspections were discussed.       

The Commission informed participants that, from 16 July 2026 onwards, Commission Implementing Regulation (EU) 2025/2091 of 17 October 2025, laying down good manufacturing practice for veterinary medicinal products, and Commission Implementing Regulation (EU) 2025/2154 of 17 October 2025, laying down good manufacturing practice for active substances used as starting materials in veterinary medicinal products, in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council, will apply to veterinary medicinal products. Despite having different legal bases, the GMP requirements for veterinary medicinal products and their active substances will remain aligned with international standards and the GMP guidelines for medicinal products for human use and their active substances.

There were no updates from the EMA.

4. Follow-up actions and any other business

Necessary revisions to ensure up-to-date information regarding all listed Parties in the Article 15.3(c) List of Contact Points under the CETA Protocol are progressing.

An audit of Health Canada by the European Commission is to be planned in the context of the listing of Canada for the importation of active substances.