Canadian new drug submission

A Canadian-specific topic!

In Canada, the process of submitting a new drug to Health Canada, the federal department responsible for regulating health products, is called a "New Drug Submission" (NDS). Here's an overview of the process:

Purpose: The NDS process allows pharmaceutical companies to submit evidence to support the safety, efficacy, and quality of a new drug product for approval in Canada.

Pre-submission requirements:

  1. Pre-submission meeting: The sponsor (pharmaceutical company) meets with Health Canada to discuss the proposed submission, including the drug's proposed indication, dosage form, and clinical trial design.
  2. Common Technical Document (CTD): The sponsor prepares a CTD, a standardized format for submitting drug applications, which includes modules on chemistry, manufacturing, and controls; non-clinical studies; and clinical studies.

Submission process:

  1. NDS application: The sponsor submits the completed CTD and supporting documents, including clinical trial data, to Health Canada.
  2. Review: Health Canada reviews the submission to ensure it meets the requirements for a complete application.
  3. Scientific review: A team of experts reviews the submission, including the drug's safety, efficacy, and quality, to determine whether it meets the standards for approval.

Post-submission requirements:

  1. Response to comments: The sponsor responds to any comments or questions raised by Health Canada during the review process.
  2. Additional information: The sponsor may be required to provide additional information or data to support the submission.
  3. Approval: If the submission is deemed complete and meets the requirements, Health Canada issues a Notice of Compliance (NOC), which allows the drug to be marketed in Canada.

Timeline: The NDS process typically takes 12-24 months, but can take longer depending on the complexity of the submission and the number of reviews required.

Fees: The sponsor is required to pay fees for the NDS process, which vary depending on the type of submission and the complexity of the review.

Regulatory pathway: The NDS process is part of the regulatory pathway for new drugs in Canada, which includes:

  1. Pre-clinical testing: Laboratory and animal studies to assess the drug's safety and efficacy.
  2. Clinical trials: Human studies to evaluate the drug's safety and efficacy in patients.
  3. NDS submission: The sponsor submits the completed CTD and supporting documents to Health Canada.
  4. Approval: Health Canada issues a Notice of Compliance (NOC) if the submission is deemed complete and meets the requirements.