New Canadian Rule Allows Rolling Data Submissions For COVID-19 Drugs, Vaccines
Enabling Timely Access To Novel Products Is Key Focus
The Canadian authorities have put in place an expedited pathway for authorizing new COVID-19 drugs and vaccines that offers a more agile approach to reviewing data than what was previously allowed.
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The Netherlands-based GetReal Institute builds on seven years of multi-stakeholder collaboration to promote greater understanding of real-world evidence.
With the COVID-19 pandemic exacerbating the challenges of recruiting patients for studies targeting catastrophic diseases and rare cancers, regulators are becoming more receptive to new ways of using real-world evidence in clinical trials.
Companies can get the European Medicines Agency’s scientific opinion for their products’ use in EU and non-EU countries at about the same time.