Snapshot

The Notice of compliance with conditions pathway has been developed by the HealthCanada of Canada.

It is an abridged review (a reliance pathway).

The sponsor is required to deliver a pre-NDS or pre-SNDS presentation to the appropriate Directorate within Health Canada outlining the evidence of effectiveness to be provided in the submission. Sponsors should submit a pre-submission meeting information package to the appropriate Directorate in advance of the meeting. For further information, sponsors are advised to contact the appropriate review Directorate. Within 10 working days of the finalization of the meeting minutes, the sponsor will be notified by Health Canada of the eligibility of the drug submission for filing and consideration under the NOC/c Policy. Should Health Canada have no objections, the sponsor may submit the drug submission for screening no later than 60 calendar days following notification of eligibility. A drug submission shall contain all the data and material required to adequately assess the safety, quality and clinical efficacy of the drug. Sponsors must, at this time, clearly state that the product is filed for consideration under the NOC with conditions policy. Drug submissions reviewed under NOC/c policy will be subject to the Management of Drug Submissions Guidance and the applicable fee regulations. Sponsors filing drug submissions for consideration under the NOC/c policy, without having completed the requirements listed above and without having received notification of eligibility, will be rejected at screening. Submissions filed for advance consideration under the NOC/c policy on the basis of promising clinical evidence are not eligible for Priority Review status. Upon acceptance at screening, such submissions will be subject to a review target of 200 calendar days (+10 days SIPD +25 days screening) and monitored in accordance with Performance Measurement standards. Consideration of an ANDS or SANDS for NOC/c status will be granted in situations where the CRP also holds the NOC/c status. In instances where the CRP does not hold the NOC/c status, the ANDS can only be considered under the NOC/c policy via an NDS/SNDS for a new indication that fits the NOC/c policy objective. ANDSs or SANDSs that references a CRP with NOC/c status will be subject to a review target of 180 days.