Health Canada is proposing to update its accelerated review pathways to get important new drugs into the market more quickly. To date, the two pathways that Health Canada uses have not demonstrated that they can identify therapeutically valuable new drugs. Drugs approved under the two pathways also have a greater likelihood of acquiring a serious safety warning post-marketing compared with drugs approved through the standard review pathway. The new proposals from Health Canada will not go far in rectifying this situation, and major changes are needed. Health Canada needs to present evidence that the changes it is proposing will actually allow these pathways to fulfill the set objectives and support health benefits for Canadians.
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