On December 1, 2025, Health Canada announced the creation of a joint program with the U.S. Food and Drug Administration (FDA) to support the establishment of a Request for Information Sharing (RIS) program for generic drugs.
Specific commitments and timelines under this program have not yet been released.
The RIS program is intended to facilitate the exchange of regulatory information, with the goal of streamlining generic drug review processes. Public information about the RIS program is currently limited with respect to the specific types of information that will be shared, how requests for information sharing will be made or fulfilled, and the potential impacts of the RIS program on regulatory processes.
However, the RIS program will fall under the framework of the Generic Drug Cluster (“Cluster”), an international forum with the following objectives:
- Achieving a common understanding of each regulatory agency’s requirements for generic drug approval and current thinking on topics related to generic drug development.
- Providing a confidential forum for the exchange of information on policies, guidance documents, and the scientific basis for decisions pertaining to those policies.
- Creating a forum for discussions on general and product/class-related scientific review issues and fostering alignment in approaches to scientific evaluation.
- Addressing long-term safety issues for generic drugs through the confidential sharing of reports.
Health Canada has participated in the Cluster since its creation in June 2021. The FDA, Health Canada, and other regulatory agencies participating in the Cluster are subject to confidentiality obligations (under FDA-mandated “Confidentiality Commitments”).
Relevant Links
Health Canada Notice: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/generic-drug-information-sharing-initiative-notice.html