19. Understanding Regulations Governing Research: Regulations

19.1 Health Canada Regulations

Research involving a drug, medical device, nutraceutical, natural health product, biologic or radiopharmaceutical may require a Clinical Trial Application or an Investigational Testing Authorization Application to Health Canada and may require authorization from the applicable division of Health Canada PRIOR to conduct of the proposed research.

Please Note: that drug trials (Investigational or otherwise) are to be conducted under "Division 5" regulations of the Therapeutic Products Directorate. For more information on Division 5 visit Health Canada - Part C, Division 5 - Drugs for Clinical Trials Involving Human Subjects

To learn more about your obligations under Health Canada regulations visit:

Clinical Trials - Drug Trials

Clinical Trials - Medical Devices

Clinical Trials - Natural Health Products/Nutraceuticals (NHP)

19.2 Food and Drug Administration (FDA) Regulations - USA

Research involving a drug, medical device, nutraceutical, or natural health product with the intention of having the data recognized for a potential future marketing application in the United States, may be required to submit an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) application to the FDA and may require authorization from them PRIOR to conduct of the proposed research.

To learn more about FDA regulations visit:

19.3 Clinical Trials in the European Union (European Commission)

Collaborators with European partners in a clinical trial should become familiar with the Medicinal Products for Human Use - Clinical Trials Regulations EU No. 536/2014

To learn more about EU regulations visit: