Canada To Open Up Priority Review To More New Drugs
Health Canada has proposed revised criteria that take account of patients' needs and the health care system when deciding whether to fast-track the review of a particular drug.
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New Canadian guidance is expected to help drug sponsors collect high-quality, real-world data that meets international evidence requirements for approval. It focuses on good practices for protocol development and data collection.
The joint review by Australia and Canada of the metastatic breast cancer drug, Verzenio, helped regulators in both jurisdictions achieve efficiencies.
New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.