A Comparison of the Drug Approval Process in the United States and Canada
Abstract
The drug approval process is comparative between the United States and Canada. Without the drug approval process, consumers would be experiencing severe health consequences, therefore, the approval process is expensive, time-consuming, and lengthy for pharmaceutical companies to ensure the compound is safe and effective for its intended use.
The electronic databases utilized to recognize applicable published articles from Embase/Ovid and PubMed. The keywords utilized to recognize the pertinent articles were the following: Drug Approval, Drug Development, Food and Drug Administration, United States, Canada, and Pharmaceuticals. The research articles excluded were: non-drug, including vaccines approval process, international regulatory organizations, articles that weren’t relevant to the study, and articles that are not in English language. There was no limit on the date the articles were published.
There are more similarities than differences in the drug approval process between Canada and the United States. Both countries contain a regulatory organization (Health Canada; FDA) that review and approve novel drugs to ensure safety and efficacy prior to marketing. Pharmaceutical companies must submit an IND application prior to the inception of clinical trials in humans. Drug approval by FDA is similar to Health Canada, where they develop guidance recommendations to assist pharma companies in complying with regulations.
The majority of the published articles focus on the comparison of the drug approval process between the United States and other countries, little-to-no articles discussed the advantages/disadvantages of the drug approval process and how the length of the approval process effects patient population.
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References
2. Prajapati V, Goswami R, Makvana P, Badjatya JK. A Review on Drug Approval Process For US, Europe And India. International Journal of Drug Regulatory Affairs. 2014;2(1):1-11. doi:10.22270/ijdra.v2i1.7
3. Holbein ME. Understanding FDA regulatory requirements for investigational new drug applications for sponsor-investigators. J Investig Med. 2009;57(6):688-694. doi:10.2310/JIM.0b013e3181afdb26.
4. D, K. M., & Pappan, J. Comparison of history and drug approval process in the United States and Europe. Indian Research Journal of Pharmacy and Science. 2018;5(1): 1310-1318. doi:10.21276/irjps.2018.5.1.9
5. Rawson NS. Time required for approval of new drugs in Canada, Australia, Sweden, the United Kingdom and the United States in 1996-1998. CMAJ. 2000 Feb 22;162(4):501-4.
6. Rawson NS. Timeliness of review and approval of new drugs in Canada from 1999 through 2001: is progress being made? ClinTher. 2003 Apr;25(4):1230-47.
doi: 10.1016/s0149-2918(03)80080-2. PMID: 12809970.
7. Reichert JM. Trends in development and approval times for new therapeutics in the United States. Nat Rev Drug Discov. 2003 Sep;2(9):695-702. doi: 10.1038/nrd1178.
8. Center for Drug Evaluation and Research. (2019, October 28). Drug development & approval process [Internet]. FDA; March 17, 2021 [cited 2022 Mar 30]. Available from:
https://www.fda.gov/drugs/development-approval-process-drugs.
9. Rawson NS, Kaitin KI. Canadian and US drug approval times and safety considerations. Ann Pharmacother. 2003 Oct;37(10):1403-8.
doi: 10.1345/aph.1D110. PMID: 14519031.
10. Comparison: Canada and United States. (n.d.) [Internet]. clinregs; March 17, 2021 [cited 2022 Mar 25]. Available from:
https://clinregs.niaid.nih.gov/country/canada/united-states#_top.
11. Center for Drug Evaluation and Research. Center for drug evaluation and Research: CDER. [Internet]. FDA; 2020 Aug 18 [cited 2022 Mar 24]. Available from:
https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder.
12. Canada, H. How Drugs are Reviewed in Canada. [Internet]. Canada.ca; 2015 Feb 12 [cited 2022 Mar 22]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fact-sheets/drugs-reviewed-canada.html.
13. Carpenter D, Zucker EJ, Avorn J. Drug-review deadlines and safety problems. N Engl J Med. 2008 Mar 27;358(13):1354-61.
doi: 10.1056/NEJMsa0706341.
14. Rawson NSB, Kaitin KI, Thomas KE, Perry G. Drug Review in Canada: A Comparison with Australia, Sweden, the United Kingdom, and the United States. Drug Information Journal. 1998;32(4):1133-1141. doi:10.1177/009286159803200433.
15. Pieterson EA. A comparison of regulatory approval times for new chemical entities in Australia, Canada, Sweden, the United Kingdom, and the United States. J Clin Pharmacol. 1992 Oct;32(10):889-96.
doi: 10.1002/j.1552-4604.1992.tb04634.x.
16. Williams CT. Food and Drug Administration Drug Approval Process: A History and Overview. NursClin North Am. 2016 Mar;51(1):1-11.
doi: 10.1016/j.cnur.2015.10.007.
17. Collins, J. F. Regulatory issues for clinical trials in humans. Epidemiologic Reviews. 2002;24(1):59-66. doi:10.1093/epirev/24.1.59.
18. Ciociola AA, Cohen LB, Kulkarni P. FDA-Related Matters Committee of the American College of Gastroenterology. How drugs are developed and approved by the FDA: current process and future directions. Am J Gastroenterol. 2014 May;109(5):620-3. doi: 10.1038/ajg.2013.407.
19. Moore TJ, Furberg CD. Development times, clinical testing, post-marketing follow-up, and safety risks for the new drugs approved by the US food and drug administration: the class of 2008. JAMA Intern Med. 2014 Jan;174(1):90-5.
doi: 10.1001/jamainternmed.2013.11813.
20. Bristow MR, Hiatt WR. The FDA regulatory process for drug and genetic diagnostic test approvals. Clin Transl Sci. 2008;1(3):188-189.
doi:10.1111/j.1752-8062.2008.00066.x.
21. Center for Drug Evaluation and Research. (2019, June 10). New drug Application (NDA). Retrieved A March 17, 2021, from https://www.fda.gov/drugs/types-applications/new-drug-application-nda.
22. Center for Drug Evaluation and Research. Best Practices for Communication between IND sponsors and FDA During Drug Development. [Internet]. FDA; 2017 Dec [cited 2022 Mar 23]. Available from:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/best-practices-communication-between-ind-sponsors-and-fda-during-drug-development.
23. Craigle V. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. J Med Libr Assoc. 2007;95(2):224-225.
doi:10.3163/1536-5050.95.2.224.
24. Lexchin J. Quality of evidence considered by Health Canada in granting full market authorization to new drugs with a conditional approval: a retrospective cohort study. BMJ Open. 2018;8:e020377.
doi: 10.1136/bmjopen-2017-020377.
25. Cheung, R. Y., & Goodwin, S. H. An overview of Canadian and US approaches to drug regulation and responses To Post-market adverse drug reactions. Journal of Diabetes Science and Technology. 2013;7(2):313-320. doi:10.1177/193229681300700205.
26. Shuchman M. Clinical trials regulation-how Canada compares. CMAJ. 2008;179(7):635-638.
doi:10.1503/cmaj.081271.
27. Institutional review Board/Independent Ethics committee and Informed Consent: Protecting research subjects in the U.S. and Foreign clinical trials. New Drug Approval Process. 2016.p. 343-358.
doi:10.3109/9781420088502-19.
28. Sandeep D S, Ashwin Raj K M, Anoop Narayanan V, Akhilesh Dubey, Jobin Jose. Regulatory Approval Process for Drugs in Canada – A Challenging Task. Research J. Pharm. And Tech. 2019;12(7):3206-3210. doi: 10.5958/0974-360X.2019.00538.9.
29. Alas, J., Godlovitch, G., Mohan, C., Jelinski, S., & Khan, A. Regulatory Framework for Conducting Clinical Research in Canada. Canadian Journal of Neurological Sciences / Journal Canadien Des Sciences Neurologiques. 2017;44(5): 469-474.
doi:10.1017/cjn.2016.458.
30. Shajarizadeh A, Hollis A. Delays in the submission of new drugs in Canada. CMAJ. 2015;187(1):E47-E51. doi:10.1503/cmaj.130814.
31. Wu, J., & Juhaeri, J. The US food and Drug administration’s risk evaluation and mitigation strategy (REMS) program – current status and future direction. Clinical Therapeutics2016;38(12):2526-2532.
doi:10.1016/j.clinthera.2016.11.007.
32. Merrill RA. Regulation of drugs and devices: an evolution. Health Aff (Millwood). Summer. 1994;13(3):47-69.
doi: 10.1377/hlthaff.13.3.47. PMID: 7927161.
33. Harris G. Drug Firms, Stymied in the Lab, Become Marketing Machines. The Wall Street Journal. [Internet]. July 6, 2000 [cited 2022 Mar 21]. Available from:
https://www.wsj.com/articles/SB962834415316648418.
34. Lin JH, Lu AY. Role of pharmacokinetics and metabolism in drug discovery and development. Pharmacol Rev. 1997 Dec;49(4):403-49.
35. Kraljevic S, Stambrook PJ, Pavelic K. Accelerating drug discovery. EMBO Rep. 2004;5(9):837-842.
doi:10.1038/sj.embor.7400236.
36. Van Norman GA. Drugs, Devices, and the FDA: Part 1: An Overview of Approval Processes for Drugs. JACC Basic Transl Sci. 2016 Apr 25;1(3):170-179.
doi: 10.1016/j.jacbts.2016.03.002.
37. Stringer S. An Overview of How the Food and Drug Administration Regulates New Drug Development in the United States. Drug Information Journal. 1996;30(3):745-751. doi:10.1177/009286159603000318.
38. Darrow JJ, Avorn J, Kesselheim AS. FDA Approval and Regulation of Pharmaceuticals, 1983-2018. JAMA. 2020 Jan 14;323(2):164-176. doi: 10.1001/jama.2019.20288.
39. Fung M, Thornton A, Mybeck K, Wu JH, Hornbuckle K, Muniz E. Evaluation of the Characteristics of Safety Withdrawal of Prescription Drugs from Worldwide Pharmaceutical Markets-1960 to 1999. Drug Information Journal. 2001;35(1):293-317.
doi:10.1177/009286150103500134.
40. Kaitin KI. The prescription Drug User Fee Act of 1992 and the new drug development process. Am J Ther. 1997 May-Jun;4(5-6):167-72.
doi: 10.1097/00045391-199705000-00002.
41. Expanded Access to Investigational Drugs for Treatment Use [Internet]. FDA; 2017 Oct [cited 2022 Mar 20]. Available from:
https://www.fda.gov/media/85675/download
42. Canada H. Government of Canada. [Internet]. Canada.ca.; 2008 Jul 30 [cited 2022 Mar 25]. Available from:
https://www.canada.ca/en/health-canada/services/food-nutrition/legislation-guidelines/acts-regulations/canada-food-drugs.html.
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