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
-
Proposal for modernizing clinical trial framework aims to improve access to new and innovative therapies in Canada
On December 20, 2025, Health Canada launched a consultation on modernizing the framework for clinical trials involving drugs for human use, including pharmaceuticals, biologics, radiopharmaceuticals, ...Read More -
Health Canada consultation on two draft guidance documents on terms and conditions for human and veterinary drugs and drug submissions based on promising evidence of clinical efficacy
As previously reported, in December 2024, Health Canada published its agile licensing amendments to the Food and Drug Regulations.Read More -
2025 highlights in Canadian life sciences IP and regulatory law
In 2025, the Rx IP Update team at Smart & Biggar reported on a number of developments in Canadian life sciences IP and regulatory law.Read More
