Health Canada and the Food and Drug Administration collaborate on generic drug information sharing initiative: Notice

December 1, 2025
Our file number: 25-107744 - 234

Health Canada's Pharmaceutical Drugs Directorate (PDD) and the U.S. Food and Drug Administration's (FDA) Office of Generic Drugs (OGD) have created a program to support the establishment of a Request for Information Sharing (RIS) program. This is a critical advancement in international collaboration. It falls under the framework of the generic drug cluster and through the confidentiality commitments established between Health Canada and FDA.

The RIS program will enhance the exchange of regulatory information to facilitate generic drug review processes. The objective is to support regulatory alignment and enhance patient access to high-quality, safe and effective generic medicines in both countries. Participation in this program is entirely voluntary and subject to the agreement of the applicant, US FDA and Health Canada.

This effort reflects a shared commitment by FDA and Health Canada to advance regulatory efficiency and leverage scientific and regulatory expertise to streamline generic drug review and approval. It will also contribute to more efficient regulatory decision-making and reduce duplication of efforts, which will support timely access to cost-effective treatments.

Learn more

• Global Generic Drug Affairs (U.S. FDA)
• Health products international activities (Health Canada)

For more information please contact: pdd-international-dmp@hc-sc.gc.ca