Guidance for market authorization requirements for COVID-19 drugs: Rolling submissions and reviews
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Standard for accepting a rolling submission
Modified requirements for COVID-19 drugs allow for the filing of rolling submissions (section C.08.002(2.3) of Canada's Food and Drug Regulations). The ability to review data from early development while later-stage clinical trials are taking place helps to expedite the regulatory review process.
Before filing an application for a rolling review, sponsors of drug products are expected to have gathered a certain level of evidence on the safety, efficacy and quality of their drug. Sponsors are encouraged to consult with us before filing an application.
To file an application for a rolling review, sponsors should have, at a minimum:
- non-clinical and clinical phase 2 data that demonstrate promising evidence of safety and efficacy
- confirmation that phase 3 trials have started and there are enough people enrolled to provide evidence of safety and efficacy within a reasonable amount of time
- expected to be within 6 months from initial filing
- evidence that manufacturing of the drug will be in compliance with good manufacturing practices (GMP) and that product quality and consistency are well controlled
Sponsors must also file an application plan giving the anticipated timelines for submitting the various components of the application. They must include this plan in the initial filing.
For details on application plan requirements, consult our guidance document:
Decisions made about COVID-19 drugs will follow processes established for reviews under the modified requirements for COVID-19 drugs. Health Canada will start rolling reviews to build towards a complete dossier for each drug. The dossier will include data to support the safety, efficacy and quality of the drug.
With the sponsor's agreement, we may also collaborate with international regulatory partners to share analyses and perspectives and to supplement Health Canada's review process.
Teams of scientific and medical experts at Health Canada will carry out the drug reviews. These people have experience in reviewing complex data and study results on the safety, efficacy and quality of a variety of drugs. Review activities include developing strategies to gather data on drug safety and effectiveness following authorization through terms and conditions and/or pharmacovigilance activities, including post-market studies.
Collaborative review with international regulatory partners may be possible when manufacturers file a rolling submission simultaneously with Health Canada and another jurisdiction with which there is a mutual collaborative agreement. While recommendations may be informed by discussions between regulatory partners during a collaborative review, authorization decisions will be based on a thorough assessment of the evidence by Health Canada. These decisions are independent of those made by international partners.
Health Canada bases decisions on the overall benefits and risks of a product. We also consider all of the data available, such as:
- the results provided in the rolling submission
- pharmacovigilance activities and risk minimization strategies
- current knowledge about the virus and disease (which will need to be continually monitored during the review and following authorization)
- information provided as part of any Terms and Conditions associated with an authorization
Sources of knowledge include the scientific literature, public health and surveillance data, and collaborations with our international regulatory partners.
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