Use of foreign reviews and decisions
This project is focussed on achieving 2 distinct goals. These are to:
- standardize the use of reviews conducted by other Regulatory Agencies (foreign reviews) to gain efficiencies in our review of submissions for prescription drugs for human use
- allow authorizations for certain drugs that meet an unmet medical need to be based on a foreign decision (This would be for certain human and veterinary drugs that have been approved by a listed foreign regulator and that have adequate post-market experience in that jurisdiction.)
This project allows for greater access to therapeutic products that meet health care system and animal health needs.
The key milestones of this project include:
- external consultations (started December 2017)
- complete policy analysis (April 2018)
- publishing draft regulations
- publishing final regulations
Canadians will have the opportunity to comment on the regulatory proposal during a public comment period, expected in spring 2020.
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