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Management Pharma Market Authorization Strategies: A guide
Pharma Market Authorization Strategies: A guide
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Full Title:
Pharma Market Authorization Strategies: A guide to launching drugs quickly and efficiently in Europe
Executive Summary
Launching a drug in Europe can be an extremely costly and time-consuming procedure, Although the centralized procedure is gaining ground as the one-stop shop for a EU-wide marketing authorization, its use is restricted to NCEs and biotechnology products. The majority of marketing authorizations are still issued by national competent authorities through the mutual recognition procedure. Pharma Market Authorization Strategies: A guide to launching drugs quickly and efficiently in Europe is a practical guide to speeding the process of launching drugs in the European market, deciding where to market first and how to build and retain market share post-authorization. This report analyzes current trends and investigates future perspectives predicted by key decision makers. Guiding the reader through the European Medicines Evaluation Agency’s centralized procedure, the report combines insider opinions and the latest data to identify which Reference Member States are the fastest, cheapest and most efficient for NCEs and generics.
