Sponsors of biologics and new drug submissions now have the option of requesting aligned regulatory reviews between Health Canada and health technology assessment (HTA) organizations.
Health Canada issued a notice
Friday that “formalizes the timelines, process, and considerations for sponsors with qualifying drug submissions” for the alternative review pathway.
Biosimilars as well as supplemental new drug submissions for new indications seeking HTA coverage recommendation on a Notice of Compliance (NOC) basis can qualify as well.
Following recent process changes for earlier submission intake, the HTAs that will be partaking in the aligned reviews are the Canadian Agency for Drugs and Technologies in Health and the l'Institut national d'excellence en santé et en services sociaux.
By submitting a completed template to Health Canada to authorize the information-sharing, sponsors can opt in at any stage during a review process, though earlier consent is encouraged. Consent can also be provided up to 30 days after receiving marketing clearance.
Sponsors can also use the principles Health Canada will apply to all aligned reviews as a guide when developing applications, as outlined in the notice These principles include limitations in the sharing of confidential information, independent decision-making, transparency, among others.
The pathway is aimed at reducing the time between when an NOC is issued and HTA recommendations are made on a submission. This is because it “allows for real-time discussions,” which in turn leads to a “greater ability to share information, more efficient resolution of review issues and reduction of duplication, where possible,” the regulator argued.
The move to open up this option is also part of a larger Health Canada initiative—Regulatory Review of Drugs and Devices—through which the regulator is looking to improve patient access.
As part of the same initiative, the regulator announced
earlier this year a new approach on digital health technologies, including a new division within the Therapeutic Products Directorate’s Medical Devices Bureau, as well as several proposed changes to its medical device regulations to strengthen post-market surveillance and risk management.