Posted by Michael Wonder on 27 Jun 2018
Health Canada offers HTA aligned reviews for drugs and biologics
25 June 2018 - Sponsors of biologics and new drug submissions now have the option of requesting aligned regulatory reviews between Health Canada and health technology assessment organisations.
Health Canada issued a notice Friday that “formalizes the timelines, process, and considerations for sponsors with qualifying drug submissions” for the alternative review pathway.
Biosimilars as well as supplemental new drug submissions for new indications seeking HTA coverage recommendation on a Notice of Compliance basis can qualify as well.
