Canada

The European Commission, the European Medicines Agency (EMA) and Health Canada have had confidentiality arrangements in place since 2007, allowing for the exchange of confidential information as part of their regulatory and scientific processes. The European union (EU) and Canada also have a mutual recognition agreement (MRA) in place on good manufacturing practice (GMP) compliance.

Confidentiality arrangement

EMA, the European Commission and Health Canada signed a confidentiality arrangement in 2007, which was renewed in 2013 and in 2020. Changes introduced in 2020 include references to personal data legislation and the permanent validity of the arrangement.

Working arrangement between EMA, Directorate-General Health and Food Safety (DG SANTE) and Department of Health Canada (Health Canada)

The confidential information that EMA and Health Canada can share includes:

• applications for scientific advice, orphan designation, marketing authorisation and post-authorisation variations;
• applications for agreement of paediatric investigation plans;
• good-clinical-practice (GCP) inspections for specific products and GCP inspection reports available to EMA or the European Commission;
• good-manufacturing-practice (GMP) inspections;
• pharmacovigilance data, particularly in relation to adverse drug reactions, as well as safety concerns arising from periodic safety update reports and post-authorisation obligations and commitments, and inspection reports;
• all legislation and guidance documents;
• information technology systems supporting regulatory processes.

Prior confidentiality arrangements and implementation

Renewal of confidentiality arrangement 2013

Renewal of confidentiality agreement: Letter from the European Medicines Agency and the European Commission to Health Canada

Letter from the European Medicines Agency and the European Commission to Health Canada: Confidentiality agreement details

Renewal of confidentiality agreement: Letter from Health Canada to the European Medicines Agency and the European Commission

Letter from Health Canada to the European Medicines Agency and the European Commission: Confidentiality agreement details

Renewal of confidentiality agreement: Confirmation letter from Health Canada to the European Medicines Agency and the European Commission

Confidentiality arrangement 2007

Letter from Health Canada

Letter from the European Commission and the European Medicines Agency

Implementation

The agencies agreed an implementation plan which describes the processes each party will undertake to facilitate the sharing of information and documents:

Implementation plan for regulatory co-operation on medicinal products April 2, 2009 - Following the exchange of letters between the EU (EC and EMEA) and Health Canada (HPFB)

 

Implementation plan for regulatory co-operation on medicinal products April 2, 2009 - Following the exchange of letters between the EU (EC and EMEA) and Health Canada (HPFB)

MRA and collaboration on GMP compliance

The EU and Canada signed a mutual recognition agreement (MRA) on good manufacturing practice (GMP). This allows EU authorities and their Canadian counterparts to:

• rely on each other's GMP inspections;
• waive batch testing of products on entry into their territories;
• share information on inspections and quality defects.

For more information on MRAs and the scope of the EU-Canada MRA, see:

• Mutual recognition agreements

EMA also participates in initiatives with partner authorities, including Health Canada, on GMP inspections which aim to better distribute inspections capacity, allowing more sites to be monitored and reducing unnecessary duplication. 

For more information, see:

• International collaboration on GMP inspections

Cluster activities

The agencies, together with other non-EU regulators, hold regular meetings by phone or videoconference in so-called 'clusters', which are areas of cooperation focusing on special topics and therapeutic areas identified as requiring an intensified exchange of information and collaboration.

For more information, see:

• Cluster activities with regulatory partners

Other areas of cooperation

Health Canada and EMA have seconded liaison officials to each other's premises on an ad hoc basis.

Following EMA's implementation of the EU pharmacovigilance legislation, EMA and Health Canada strengthened their cooperation on pharmacovigilance activities, including sharing advice on continuous improvement for business operations, development of performance indicators and methods for reporting on the impact of pharmacovigilance.

For more information, see:

• EU pharmacovigilance legislation