On November 27, 2017, Health Canada announced the release of Guidance Document: Use of a Foreign-sourced Reference Product as a Canadian Reference Product. The Guidance, which replaces Health Canada's 1995 Canadian Reference Product ("CRP") policy and is effective as of November 24, 2017, is directed to sponsors of all Abbreviated New Drug Submissions or Abbreviated Extraordinary Use New Drug Submissions that seek to obtain approval based on a demonstration of pharmaceutical equivalence and bioequivalence to a reference drug product marketed in a country other than Canada (i.e., under the CRP definition provided in paragraph (c) of section C.08.001.1 of the Food and Drug Regulations).
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