ARTICLE
18 December 2025

Health Canada And U.S. FDA Agree To Establish Information Sharing Program For Generic Drug Submission Reviews

SB
Smart & Biggar

Contributor

Smart & Biggar uncovers and maximizes intellectual property and technology assets for our clients. Today’s fast-paced innovation economy demands a higher level of expertise and attention to detail when it comes to IP strategy and protection. With over 125 lawyers, patent agents and trademark agents collaborating across five Canadian offices, Smart & Biggar is trusted by the world’s leading innovators to find value in their IP rights. As market leaders in IP, Smart & Biggar’s team is on the pulse when it comes to the latest developments and the wider industry changes that impact our clients. To stay informed, visit smartbiggar.ca/insights, including access to our RxIP Update (smartbiggar.ca/insights/rx-ip-updates), a monthly digest of the latest decisions and law surrounding the life sciences and pharmaceutical industries.
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...
Canada Food, Drugs, Healthcare, Life Sciences

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.

The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.

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