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Found 10 records similar to Regulations amending the food and drug regulations (1024 - clinical trials)

Federal

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.

Last Updated: Jun. 7, 2022
Date Published: Feb. 4, 2022
Organization: Health Canada
Formats: HTML
Keywords:  regulatory-innovation for health-products, regulatory-innovation for health-products, clinical-trials, regulatory innovation, modernizing clinical-trial regulations
Federal

Consultation on guidance document: Drugs for Clinical Trials Involving Human Subjects.

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  consultation, guidance document, drugs for clinical-trials, drugs involving human-subjects
Federal

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).

Last Updated: Jun. 7, 2022
Date Published: Jan. 25, 2021
Organization: Health Canada
Formats: HTML
Keywords:  agile regulations, advanced therapeutic products, clinical trials, Health-and-Biosciences Sector, regulatory review roadmap, regulatory modernization commitments, modernize-the-regulations for clinical-trials, advanced therapeutic products, ATPs
Federal

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.

Last Updated: Jun. 7, 2022
Date Published: May 3, 2021
Organization: Health Canada
Formats: HTML
Keywords:  clinical-trials, clinical-trials and drug-safety, drugs used-in clinical-trials, possible benefits-and-risks, dug safety-and-efficacy, authorized drug
Federal

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.

Last Updated: Jun. 7, 2022
Date Published: Mar. 2, 2022
Organization: Health Canada
Formats: HTML
Keywords:  Management of clinical-trials, clinical-trials during COVID-19, clinical-trials during pandemic, notice to clinical-trial-sponsors
Federal

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.

Last Updated: Jun. 7, 2022
Date Published: May 18, 2018
Organization: Health Canada
Formats: HTML
Keywords:  clinical-trial-application, clinical-trial-application process, clinical-trial, clinical-trial sponsors, file a clinical-trial-application, CTA, human drug clinical-trials
Federal

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.

Last Updated: Jun. 7, 2022
Date Published: Sep. 20, 2021
Organization: Health Canada
Formats: HTML
Keywords:  clinical trial, clinical trial applications-amendments, Ministerial Order, clinical-trial review period, extend review period
Federal

The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices.

Last Updated: Jun. 7, 2022
Date Published: Apr. 6, 2022
Organization: Health Canada
Formats: HTML
Keywords:  clinical-trials, clinical-trials for COVID-19-medical-devices, list of authorized-clinical-trials
Federal

Health Canada answers to frequently asked questions about drug importation and record keeping for clinical trials

Last Updated: Jun. 7, 2022
Date Published: Jun. 1, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Clinical trials, drug importation, record-keeping for clinical-trials, frequently asked questions
Federal

Provides answers to frequently asked questions about Health Canada filing requirements for clinical trials

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  clinical trials, frequently asked questions, filing of clinical-trials, filing-requirements for clinical-trials
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