Notice: Consultation on draft guidance on management of rolling reviews for drug submissions
On December 17, 2022, Health Canada pre-published in Canada Gazette, Part I, amendments to the Food and Drug Regulations (FDR). The amendments are titled Regulations Amending Certain Regulations made under the Food and Drugs Act (Agile Regulations).
This regulatory proposal includes new provisions that enable the rolling review of a new drug submission (NDS) or supplement to a new drug submission (SNDS) that meets specific eligibility conditions.
Health Canada has developed the draft Guidance on management of rolling reviews for drug submissions to:
- provide an overview of the proposed regulatory requirements for rolling reviews
- provide a consistent interpretation of the provisions in the regulations that pertain to rolling reviews
- clarify the process by which a sponsor may apply for rolling review status for a forthcoming drug submission
- give information about the rolling review process and related requirements after a rolling review application package is approved and a drug submission is then filed
This guidance document applies to drugs for human and veterinary use regulated by Health Canada’s Health Products and Food Branch in accordance with the Food and Drugs Act and its regulations.
It does not apply to submissions eligible for a rolling review for a public health emergency drug for COVID-19 or a condition described in the incorporated by reference List of Conditions that Threaten Public Health in Canada. Please consult the draft Guidance on the Food and Drug Regulations for public health emergency drugs. It is being posted at the same time for stakeholder comments.
Feedback was requested on the draft Guidance on management of rolling reviews for drug submissions from December 17, 2022 to April 26, 2023. For more information, please visit the consultation page.
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