The European Medicines Agency and the European Commission’s Directorate General for Health and Consumers have renewed their confidentiality arrangement with the Health Products and Food Branch of Health Canada, the Canadian regulatory authority for medicines, for a further five-year period.
The renewal builds on the success of the original 2007 confidentiality arrangement. It will allow the two parties to continue to exchange regulatory information related to the authorisation and supervision of medicinal products for human and animal use for a further period of five years, with tacit renewal for subsequent five-year periods.
The type of confidential information that the Agency may share with Health Canada includes, but is not limited to:
- all legislation and guidance documents available under the rules and regulations governing medicinal products in the European Union (EU);
- post-authorisation pharmacovigilance data, particularly those of an urgent nature related to adverse drug reactions originating from within or outside the EU, as well as safety concerns arising from periodic safety update reports and post-authorisation obligations and commitments;
- information contained in applications for scientific advice, orphan designation, marketing authorisation or post-authorisation activities of significant public-health interest, and applications for agreement of paediatric investigation plans;
- good-clinical-practice (GCP) inspections for specific products and GCP inspection reports available to the Agency or the Directorate General for Health and Consumers;
- information-technology systems supporting regulatory processes.
The new five-year confidentiality arrangement became operational on 22 February 2013.