Use of foreign reviews and decisions

This project is focussed on achieving 2 distinct goals. These are to:

1. 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
2. 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.