Health Canada and the U.S. Food and Drug Administration (FDA) have created a program to support the establishment of a Request for Information Sharing (RIS) program, which will enhance the exchange of regulatory information to facilitate the drug review processes for generic drugs. This advances Health Canada’s efforts in international collaboration, which we recently reported on in connection with Health Canada’s “Red Tape Review”.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
Related Publications & Articles
-
Medical devices updates: mandatory use of the regulatory enrolment process for medical devices and updated guidance documents related to the regulatory enrolment process
Health Canada released a notice to industry on April 24, 2026, outlining that manufacturers must use the Regulatory Enrolment Process (REP) and Common Electronic Submission Gateway (CESG) for medical ...Read More -
Health Canada seeks feedback on phased implementation of the incorporated by reference list for Ministerial Reliance Order
As previously reported, Health Canada has proposed a Ministerial Reliance Order that would allow Health Canada to rely on decisions of foreign regulatory authorities (FRAs). Health Canada has proposed...Read More -
Health Canada finalizes biosimilar guidance: comparative clinical efficacy studies not typically required
In Canada, biosimilar products are approved by way of a new drug submission, following Health Canada guidance first released in 2010 and significantly revised in 2016.Read More
