Drugs (ICS code: 11.120)

Clinical Trials Regulations (145 pages, available in English and French) & Regulations Amending Certain Regulations Relating to Clinical Trials (8 pages, available in English and French)

The proposed Regulations would establish a new, standalone regulatory framework under the Food and Drugs Act for clinical trials involving drugs for human use. This proposed framework would replace the existing clinical trial regulatory schemes for drugs in Part C, Division 5 of the Food and Drug Regulations (FDR) and Part 2 of the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (COVID-19 CT Regulations). It would regulate both the conduct of clinical trials and the importation and sale of drugs used in these trials. Specifically, it would establish requirements for the importation and sale of drugs to be used in a clinical trial as well as the application process for the issuance of an authorization to conduct a trial and the oversight mechanisms. It would also set out requirements for good clinical practices, reporting, and other activities related to clinical trials. Additionally, the proposed Regulations would repeal Part C, Division 5 of the FDR and Part 2 of the COVID-19 CT Regulations and would make several consequential amendments to other provisions of the FDR, the COVID-19 CT Regulations and other related regulations to align them with the new framework.