How Drugs are reviewed in Canada

  1. Therapeutic Products Directorate (TPD) of Health Canada Review drug before approving them to sale in Country
  2. What is TPD: National authority to regulate, evaluate, monitor safety, efficacy, and quality of therapeutic and diagnostic products. TDP make sure all products meet Food and Drugs Act
  3. Does TPD involves in per commercialization review?: Yes, TDP reviews clinical trial information submitted in a clinical trial application
  4. What sponsor should do after a successful clinical trial?: File for NDS (New Drug Submission) with TPD
  5. How long it takes to review Drug?: 18 months from NDS to TPD marketing decision. This time may vary based on many factors
  6. How to get Drugs currently not available in Canada? Under Special Access Program, a legitimate need is approved by TPD
  7. How TPD monitor post-market approval?: Drug distributor keep TPD informed of adverse effects and new safety information
  8. Who monitors Manufacturing facility?: TPD Licenses most drug production sites and conduct regular inspection
  9. What are steps in Drug review process?:
  • File NDS to TPD
  • TPD Review file
  • TPD assess potential benefits and risks of the drugs
  • TPD review Sponsor information directed to practitioners and consumers
  • TPD provides NOC (Notice of Compliance) and DIN (Drug Identification Number)
Source: PDF

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