CADTH Establishes New Post-Market Drug Evaluation Program

OTTAWA, February 4, 2022 ─ CADTH is pleased to announce it is expanding its expertise in the management of pharmaceuticals in Canada with the creation of a new Post-Market Drug Evaluation (PMDE) Program.

The PMDE Program will be responsible for launching and coordinating a network that leverages Canadian expertise in applied drug research, methodology, and data analysis. The program’s aim will be to deliver timely and credible evidence on the post-market safety and effectiveness of drugs approved for use in Canada.

The creation of CADTH’s PMDE Program follows the fall 2021 announcement by the Canadian Institutes of Health Research (CIHR) and Health Canada of their intention to give CADTH responsibility for the important work of the Drug Safety and Effectiveness Network (DSEN). DSEN was established by CIHR and Health Canada in 2009 to increase Canada’s capacity to undertake high-quality post-market drug research.

“The creation of the Post-Market Drug Evaluation Program means decision-makers can turn to CADTH for advice across the life cycle of a drug, starting before a drug is approved through to its use in the real world.” said CADTH President and Chief Executive Officer Suzanne McGurn.

“Understanding the safety and effectiveness of drugs in use has always been critical, and when new drugs come to market with uncertainty about their long-term effectiveness, there is a vital need for CADTH to provide a responsive and systemic approach to delivering post-market evidence.”

On February 8, 2022 CADTH will host an information session to provide researchers and other stakeholders with details about the PMDE Program. The session will also offer guidance for potential applicants, including researchers and methodologists, on how to respond to the 2 Request for Proposals for grant funding.

The CADTH program will have a similar function to those that exist in other countries such as the SENTINEL Initiative of the US FDA and the SIGMA Consortium, an alliance of European Network of Centres of Pharmacoepidemiology and Pharmacovigilance (ENCePP) research centres. CADTH’s PMDE Program will be fully operational by September 2022.

Associated links

• Register for the information session on CADTH’s PMDE Program.
• Visit the PMDE website and, for detailed information on the program, refer to CADTH’s PMDE Program Overview.
• Learn about the Request for Proposal Grant Award.
• Subscribe to receive updates from CADTH.

Quick facts

• DSEN was established by CIHR and Health Canada in 2009 to fill gaps in information for federal, provincial, and territorial decision-makers on the evidence of the safety and effectiveness of drugs used in real-world settings, and to increase Canada’s capacity to undertake high-quality post-market research.
• On August 13, 2021 CIHR and Health Canada announced the intent to transfer the responsibility for the work of DSEN to CADTH by September 2022. Until then, DSEN continues to accept new queries through CIHR’s DSEN Coordinating Office at [email protected].

About CADTH

CADTH is an independent, not-for-profit agency funded by Canadian federal, provincial, and territorial governments (with the exception of Quebec) to provide credible, impartial advice and evidence-based information about the effectiveness of drugs and other health technologies to Canadian health care decision-makers.

For further information: [email protected], 613-614-6863