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