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.
Within Health Canada, the Health Products and Food Branch deals with issues concerning EMA.
EMA, the European Commission and Health Canada signed a confidentiality arrangement in 2007, which was renewed in 2013 for a further period of five years, with tacit renewal for subsequent five-year periods.
The confidential information that EMA and Health Canada can share includes:
- all legislation and guidance documents;
- post-authorisation 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;
- applications for scientific advice, orphan designation, marketing authorisation or post-authorisation activities of significant public health interest;
- 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;
- information technology systems supporting regulatory processes.
Exchange of letters
Renewal of confidentiality arrangement 2013
- Renewal of confidentiality arrangement - Letter from the European Commission and EMA
- Confidentiality arrangement details - Letter from the European Commission and EMA
- Renewal of confidentiality arrangement - Letter from Health Canada
- Confidentiality arrangementt details - Letter from Health Canada
- Confirmation letter from Health Canada
Confidentiality arrangement 2007
- Confidentiality arrangement - Letter from the European Commission and EMA
- Confidentiality arrangement - Letter from Health Canada
The agencies have 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 - Following the exchange of letters between the EU and Health Canada (8/4/2009) (EN)
- Implementation plan for regulatory co-operation on medicinal products - Following the exchange of letters between the EU and Health Canada (8/4/2009) (FR)
MRA and collaboration on GMP compliance
- 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.
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
Helath 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 strenghtened 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.