Health Canada is proposing new amendments to the Food and Drug Regulations and Medical Devices Regulations. Part of these amendments include “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.”
The amendments will allow a sponsor to apply for a rolling review status for forthcoming drug submissions should they meet specific eligibility conditions.
This rolling review status will allow a sponsor to file a drug submission without all of the necessary information to Health Canada regarding the drug’s safety, efficacy, and quality. Once a drug submission has been filed, the sponsor will have a set period of time in which to provide the information that was missing.
It is important to note that eligibility for a rolling review will not change the safety, efficacy, and quality requirements outlined in Part C of the associated regulations.
Health Canada has experience with rolling reviews, previously having used them to support timely access to drugs that reduce the risk of certain infectious diseases.
Annual strain updates of influenza vaccines and the experience from the COVID-19 pandemic are examples of how Health Canada has used these rolling reviews in the past.
With this experience, Health Canada is now giving sponsors an option to submit eligible drug submissions without all the required information. The sponsor will still be required to submit the missing information but must produce that information within by a specified time.
This draft guidance document is for sponsors who want to apply for rolling review status for an upcoming drug submission and sponsors who have filed a submission that has been granted rolling review status.
The document also applies to rolling reviews of drug submissions that are related to vaccines under the “List of Influenza Vaccines for Which Supplements to New Drug Submissions Can be Filled“.
The scope of this draft guidance document includes drugs for human and veterinary use, regulated under The Health Products and Food Branch in accordance with the Food and Drugs Act (act) and its regulations.
This guidance document does not apply to the following submissions:
The rolling review option does not apply to the following:
The objective of this change is to provide an option to allow information for an eligible new drug submission or supplement to a new drug submission (SNDS) to be provided to Health Canada after the submission has already been filed. Additionally, this change will help resolve issues earlier in the rolling review process and allow more opportunities for interactions between Health Canada and the sponsor. All of this will help to facilitate access to the Canadian market earlier, provided evidence of safety, efficacy, and quality has been presented.
Rolling reviews will continue Health Canada’s transparency initiative for human drugs. They will continue to communicate the most up-to-date information about drugs for human and veterinary use.
This article provides a supplemental review of Health Canada’s draft guidance document, “Draft guidance on management of rolling reviews for drug submissions: Overview“, and is not a substitute for reading the full draft guidance.
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