European and Canadian regulators have forged a transatlantic agreement to exchange confidential information about the authorisation and safety of medicines.
The sharing of expertise is an attempt to strengthen protection of public health and allow both authorities to act faster in the event of a safety scare.
The agreement was made between Health Canada, the European Commission and the European Medicines Agency in Brussels in December, and its partners will exchange private information on issues with marketed medicines and products being considered for authorisation.
The confidentiality is due to the nature of some of the information, which will include, but not be restricted to, legislation documents, post authorisation pharmaconvigilance, good clinical practice inspections for products and the information technology systems supporting regulations.
The agreement doesn't create any kind of legal obligation on the participants and will run for five years, after which its effectiveness will be assessed.
Pharmafocus
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