Priority Review vs NOC/c – Which Pathway is Right for Me?
Drug development and innovation is incredibly important to those with life-threatening and severely debilitating conditions. The process of getting a drug from discovery to the market is lengthy, taking an average of 10 years. However, expediting the process is difficult, as research and clinical trials take up a significant amount of time and cannot be rushed. For those with severe conditions, having access to a new drug even a few months sooner can significantly improve quality of life and potentially save lives. Regulatory agencies understand the importance of getting these medications into the hands of patients sooner rather than later, and therefore have created expedited review pathways to lessen the time to market.
In Canada, there are currently no specific regulatory provisions for drugs for rare diseases (“orphan drugs”), however, there are two main accelerated review pathways. These pathways are known as “Priority Review” and “Advance Consideration under the Notice of Compliance with Conditions (NOC/c) Policy”. The pathways are similar in that they are both intended for therapies to address serious and life-threatening/severely debilitating conditions, however, there are also some key differences to note.
The Priority Review pathway provides an accelerated review of drugs for life-threatening or severely debilitating conditions for which there are few effective therapies already on the market. Health Canada’s review target for a Priority Review submission is 180 days, just over half the time of a standard New Drug Submission (NDS) review target of 300 days.
The new drug may only be considered for Priority Review if the sponsor can provide substantial evidence (typically at least two adequate and well controlled clinical studies) of clinical effectiveness that the drug provides:
- Effective treatment, prevention or diagnosis of a disease or condition for which no drug is presently marketed in Canada; or,
- A significant increase in efficacy and/or significant decrease in risk such that the overall benefit/risk profile is improved over existing therapies
Priority Review is requested in advance of submitting an NDS by submitting a Clinical Assessment Package. The clinical data and rationale will be reviewed by Health Canada within 30 days of receipt. If Health Canada deems the drug eligible for Priority Review status, they will grant a format designation of Priority Review and the NDS must be filed within 60 days. The likelihood of being granted Priority Review can be discussed during an optional pre-NDS meeting. It should be noted that following approval of a Priority Review NDS, the product must also be marketed within 60 days of receiving the NOC.
Advance Consideration under the NOC/c Policy
The Advance Consideration for NOC/c pathway facilitates earlier access to drugs, for a serious, life-threatening, or debilitating disease before there is definitive evidence of safety and effectiveness. The drug must have:
- Promising evidence of efficacy;
- Adequate evidence of safety; and,
- Potential to provide effective treatment for which no drug is currently marketed in Canada or a significant increase in efficacy/reduction in risk for a disease/condition not adequately managed by a drug marketed in Canada.
Health Canada’s review target for a submission under the NOC/c pathway is 200 days. Unlike the Priority Review pathway, a meeting with Health Canada is mandatory, as it triggers the request for Advance Consideration for NOC/c. Health Canada will decide if the drug is eligible for Advance Consideration for NOC/c within 10 days of the meeting minutes being finalized, and an NDS must be submitted within 60 days of the decision. Prior to NOC/c authorization, the sponsor must submit a letter of undertaking (LoU) that describes post-approval commitments (e.g., conducting additional studies, or creation of a patient registry).
Priority Review vs. Advance Consideration
The table below highlights the distinguishing features of the Priority Review and Advance Consideration pathways.
|Priority Review||Advance Consideration|
|Intended Use||Serious, life-threatening, or severely debilitating conditions||Serious, life-threatening, or severely debilitating conditions|
|Evidence Required||Substantial evidence of clinical effectiveness||Promising evidence of clinical effectiveness|
|Request||Written request for Priority Review status/Clinical Assessment Package
(Pre-NDS meeting is optional)
|Finalized Pre-NDS meeting minutes|
|Confirming Eligibility||Within 30 days of receipt of the request||Within 10 working days of the finalization of the meeting minutes|
|Submission Filing Timelines||Within 60 calendar days of the date of notification of eligibility for review under the Priority Review pathway||Within 60 calendar days from the date of notification of eligibility for review under the Advance Consideration pathway|
|Approval||Full approval (NOC) or conditional approval if more confirmatory evidence is required (NOC/c)||Conditional approval (NOC/c)|
|Post-Approval Commitments||Applicable if a NOC/c is granted; May include results from confirmatory trials and additional commitments may be required in the Letter of Undertaking||May include results from confirmatory trials and additional commitments may be required in the Letter of Undertaking|
How can Intrinsik help?
Intrinsik’s regulatory team has filed several New Drug Submissions under the Priority Review and Advance Consideration for NOC/c pathways. We provide our clients with regulatory support throughout the pre-submission and post-approval stages. Our support includes leading sponsors in agency meetings, medical and technical writing services (including product label development and review), drafting of region specific administrative documents, and eCTD publishing.
For more information on how Intrinsik can help your company, please contact moc.k1638913186isnir1638913186tni@o1638913186fni1638913186.
Mahshad Farmanbar, Regulatory Affairs Associate