Canada extends non-COVID clinical trial review times

Regulatory NewsRegulatory News | 17 August 2020 |  By 

Health Canada will have an additional 15 days to review clinical trial applications for drugs that are unrelated to the coronavirus disease (COVID-19) pandemic through 16 November, after Canada’s Minister of Health Patricia Hajdu ordered the extension last week.
Normally, Health Canada has 30 days to review clinical trial applications and amendments for drugs submitted under Division 5 of the country’s Food and Drug Regulations. If the agency does not object to an application or amendment within 30 days, the application or amendment is authorized by default.
“The influx of COVID-19-related clinical trial applications is making it difficult for Health Canada to review all applications and amendments in the 30-day period. Authorizing these by default could expose clinical trial participants to undue risk, as Health Canada would have been unable to complete the health and safety assessment,” the agency explains.
The 45-day review period applies retroactively to applications and amendments for clinical trials submitted up to 30 days prior to the order’s entry into force on 13 August and will cover applications and amendments submitted through 16 November.
Health Canada says the order “will not impact clinical trial applications for the prevention, mitigation or treatment of COVID-19, which will continue to be expedited.”


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