Health Canada, CADTH, and INESSS Collaborate to Align Drug Review Processes

A new joint process furthers efforts to reduce the time between market authorization and reimbursement recommendations for public drug plans

Health Canada, CADTH, and Quebec’s Institut national d’excellence en santé et en services sociaux (INESSS) are stepping up their efforts to align drug reviews to support the affordability, accessibility, and appropriate use of prescription drugs in Canada.

As part of Health Canada’s Regulatory Review of Drugs and Devices initiative, these three organizations are pleased to announce that drug manufacturers now have the option to participate in a formalized, aligned review process for all submissions that qualify, including new drugs and drugs for new indications.

Today’s announcement formalizes the timelines of this new pathway and describes the process for manufacturers with qualifying drug submissions that might consider participating in an aligned review between Health Canada, CADTH (through its Common Drug Review and pan-Canadian Oncology Drug Review programs), and INESSS. It also outlines the key benefits of aligned reviews, including:

  • reducing delays between Health Canada’s approval of a drug and the recommendations that CADTH and INESSS issue to advise public drug plans of how drugs should be reimbursed
  • improving communication between the organizations and allowing for real-time discussions that can help reduce duplication.

“While Health Canada and health technology assessment organizations like CADTH and INESSS have different responsibilities, we share a common goal of helping ensure that all Canadians have access to effective therapies that bring value to patients and our health systems,” said CADTH Vice-President (acting) of Pharmaceutical Reviews, Heather Logan. “The new aligned review process is an important example of how greater collaboration can help us close gaps, reduce delays, and enhance the management of pharmaceuticals in Canada.”

For further details on the new process, please consult Health Canada’s Notice to Industry. In the coming months, a webinar featuring Health Canada, CADTH, and INESSS will provide all interested parties with more information about the process.

The Path to an Aligned Drug Review Process

For some time key partners have recognized the need to further align the review processes within Canada’s robust drug approval system. In response to this need, Health Canada launched its Regulatory Review of Drugs and Devices initiative to allow for greater collaboration among those organizations working to make the regulatory environment more responsive to the needs of Canada’s health care systems.

An early outcome from this collaboration was announced in March 2018, when CADTH implemented a significant operational change that now sees the Common Drug Review program accepting drug submissions up to six months (180 days) beforethe anticipated receipt of Health Canada’s approval (known as a Notice of Compliance). This was an important step toward potentially eliminating delays between Health Canada’s regulatory approval and the reimbursement recommendations that CADTH delivers to the participating public drug plans.

In addition to the process changes described above, a 2017 pilot project between CADTH’s pan-Canadian Oncology Drug Review (pCODR) program and Health Canada’s Bureau of Metabolism, Oncology, and Reproductive Services (BMORS) provided an important foundation for establishing an aligned review process. During the pilot project, pCODR and BMORS explored how greater information sharing during the review process could help align drug reviews.

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