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.
EU reviewers have recommended five new medicines and a pneumococcal vaccine for EU-wide approval. New uses of several approved medicines have also drawn the thumbs up, while the sponsor of a cancer drug has withdrawn its product from the review process.