This article introduces the roles of HTA bodies within the EU member states healthcare system and provides key elements to consider for manufacturers, which would like to enter such geographical market, on key elements to consider. In addition solutions to maximize the product development strategy are discussed, with the intention of bridging regulatory and market access gaps.
Daniel Muscionico, PharmD, MPH, MBA, Paloma Grasser, MTIM, BSc, Rosa Mouchotte, MSc, RAC and Anne Rambaud
April 2016 – Regulatory Affairs Professionals Society
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