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16 January 2019
As previously reported, Health Canada advised that beginning on 1 October 2018, it would implement certain proposals for its prescription drug product transparency initiatives (for further details please see "Health Canada to implement further pre-market transparency initiatives for prescription drugs"). In particular, Health Canada will start providing regulatory decision summaries for the approval of certain drugs approved on the basis of abbreviated new drug submissions. For submissions accepted into review on or after 1 October 2018, Health Canada now provides the following information:
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