On December 18, 2017, Health Canada published a Notice soliciting comments and recommendations from stakeholders regarding potential changes to its Guidance Document: Use of a Foreign-sourced Reference Product as a Canadian Reference Product. The Guidance, which took effect November 24, 2017 (previously reported), 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 Canadian Reference Product definition provided in paragraph (c) of section C.08.001.1 of the Food and Drug Regulations). Stakeholder feedback, preferably in electronic form, should be submitted to Health Canada by March 18, 2018.
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