Canada Drug Product Registration

New Drug Submission Process in Canada

The drug approval pathways in Canada are as follows:

1. Regular New Drug Submission Process in Canada – NDS

• NDS is the regulatory process required by Health Canada that pharmaceutical companies are required to go through to bring their new drugs into the market.
• All relevant information on the medication, including non-clinical, clinical, and quality data that addresses its safety and efficacy and overall quality (chemistry, manufacturing, and controls), must be included in the submission.
• After reviewing this data, Health Canada decides if the medication is safe, effective (positive benefit vs. risk ratio), and of excellent quality for the intended purpose. It can only then be authorized for public sale.
• The standard duration for the scientific assessment of the NDS is 300 days, comprising a preliminary screening phase lasting 45 days and an additional 10 days dedicated to technical processing.

2. Priority Review New Drug Submission Process in Canada – PR NDS

• When a new drug reaches the end of its clinical development program and is thought to have the potential to significantly outperform existing therapies (when available) for serious or life-threatening conditions, it is submitted to Health Canada as a Priority Review (PR) New Drug Submission (NDS).
• PR NDSs are prioritized over standard NDSs and are scientifically reviewed within 180 days, rather than the standard review time of 300 days.
• The goal of this accelerated review procedure is to enable people in need to receive new, cutting-edge medicines faster.
• Rather than going through the normal NDS procedure, the sponsor must seek a PR through a formal request accompanied by a Clinical Assessment Package, providing adequate evidence and a scientific justification for why the submission should be given PR.

3. Notice of Compliance with Conditions – NOC/c NDS

• It allows a sponsor to bring a new drug into market during the clinical development process, and therefore more quickly, in exchange for accepting to complete the clinical development program agreed upon with Health Canada.
• After a medicine is approved, a sponsor must abide by the terms of approval under the NOC/c policy.
• When there are encouraging indications of clinical benefit based on the available data, NDSs and SNDSs for serious, life-threatening, or severely disabling illnesses are eligible for advanced consideration for a NOC/c.

4. Drug Submissions Relying on Third-Party Data (Literature and Market Experience)

• This is the process of proving a drug’s safety and effectiveness without using clinical research findings, by using existing scientific literature or data provided by third parties. In Canada, a Supplemental New Drug Submission (SNDS) or a New Drug Submission (NDS) may be supported by literature.
• If the submission meets HC’s requirements, this method saves time and money for the sponsor and HC. To support the safety and effectiveness of the medicine under consideration and to comply with the most recent rules, guidelines, and recommendations, the literature must be pertinent, trustworthy, and sufficient. The same as for any other NDS or SNDS, the criteria for chemical, manufacturing, and controls (quality) data apply.
• In addition to the channels outlined above, HC investigates other avenues to support drug development to solve unmet medical requirements and optimize internal procedures. Some of these avenues include: The Australia-Canada-Singapore-Switzerland (ACSS) Consortium involves the utilization of overseas evaluations and rulings.

5. After the Notice of Compliance – NOC

• After reviewing the submission, Health will issue a Notice of Compliance (NOC), allowing the sponsor to market the medicine in Canada, provided the drug is safe and effective for its population.