White Paper: Market Applications & Incentives for Drug Commercialization in North America & Europe
Published June 2021
Abstract:
Health Canada, the FDA, and the EMA have similar application incentives to support and expedite the development of treatments for targeted diseases. This white paper examines application types, corresponding regulations, the purpose of each application type, submission content requirements, market exclusivity associated with each application type, and submission fees.
Keywords: FDA, NDA, Health Canada NDS, EMA, eCTD, CMC, API, market exclusivity, biosimilar, clinical data, non-clinical studies, generic drugs, bioavailability studies, orphan drugs
Click here to view White paper: Market Applications & Incentives for Drug Commercialization in North America & Europe