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Found 10 records similar to Regulations amending the food and drug regulations (1024 - clinical trials)
Clinical trials are an important step in health product development. As products evolve, so do clinical trial types and designs. Clinical trial studies increasingly focus on individualized treatments rather than larger patient groups. New technologies are also changing the way we conduct studies.
Consultation on guidance document: Drugs for Clinical Trials Involving Human Subjects.
The Health and Biosciences Sector Regulatory Review Roadmap outlined a number of regulatory modernization commitments. These included plans to modernize the regulations for clinical trials and advanced therapeutic products (ATPs).
Clinical trials can be an important treatment option. However, like all drugs, the drugs used in clinical trials have possible benefits and risks. There is often less information about the safety and efficacy of a drug being studied in a clinical trial than for an authorized drug.
As set out in paragraph C.05.010(b) of the Food and Drug Regulations (FDR), clinical trials must follow certain requirements of the protocol. Health Canada authorizes this protocol and the Research Ethics Board approves it. During the pandemic, there may be more deviations from the established protocol.
Depending on the type of clinical trial, sponsors may be required to file a Clinical Trial Application (CTA) for human drug clinical trials. Instances where a CTA must be filed are summarized in the chart below.
This Ministerial Order (MO) will give Health Canada an additional 15 days to review all clinical trial applications and amendments submitted under Division 5 of the Food and Drug Regulations.
The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices.
Health Canada answers to frequently asked questions about drug importation and record keeping for clinical trials
Provides answers to frequently asked questions about Health Canada filing requirements for clinical trials