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

Basic information about Canadian Healthcare and Pharmaceutical

  1. Universal healthcare: Everyone in the country who has Permanent residence or Citizen is covered
  2. County spends 12.5% of GDP on healthcare
  3. 2.6 doctors and 10.3 Nurse per 1000 patients are available in service
  4. Per capita spending around $3000/yr
  5. Life Expectancy ~80 years
  6. Out of 100, 66% Visits to doctors get prescriptions
  7. Most of the Government spending on pharmaceutical is on anti-TNF drugs and Biologics, and anti-Viral drugs. Most public dollar is spent on Rheumatoid arthritis, Crohn’s disease, and Hepatitis C drugs.
  8. Spendings on Statin has been reduced in comparison to previous years.
  9. Government initiative of Pan -Canadian Pharmaceutical Alliance has reduced drug spending by $0.5 billion.
  10. Generic Pricing Policy lead to $ saving and has been offset by spending on Biologics
  11. Public sector spending on drugs is increasing by 4% whereas Private by 2%
  12. Prescription Drug spending split in 2014: $29.4 bn, 43% by Public, 35% by Private, 22% is out of pocket
Source CIHI