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Canada To Speed Market Access With Aligned HTA And Marketing Authorization Reviews

Executive Summary

Drug sponsors can opt into the newly launched Canadian parallel review scheme at any stage of the marketing authorization review process, but the earlier they do so the better.

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Health Canada & HTA Body CADTH To Offer Parallel Scientific Advice

Canada has launched a new initiative under which drug sponsors will be able to request parallel scientific advice for regulatory and health technology assessment purposes.

Canada Plans Parallel HTA And Marketing Authorization Reviews

Canada plans to run regulatory reviews and health technology appraisals in parallel for certain new medicines. This could mean some companies get their drugs listed on public health plans almost immediately upon market authorization, rather than having to wait for more than a year.

New EU Approvals

The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with three new products including Novartis's Beovu for treating neovascular (wet) age related macular degeneration. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).

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