A-Model-of-European-Medicine-Agency-(EMA)'s-Decisions-on-Human-Medicines

This paper is aimed at examining the European medicine agency decisions in the field of human medicines. Different classes of human medicines approved in the last five years have been classified. They have been analyzed considering: i) the relation between non generic drugs and generic drugs, ii) time of approval, iii) objectives of the clinical trials, iv) criteria of efficiency, efficacy, safety. By using the Summary of the European Public Assessment Report for every human medicine in the period 2010-2015, a dataset has been arranged. A Structural Equation Model analysis was carried out. The degree of efficiency, the degree of safety, the tradeoff between efficiency and safety that lead to the EMA approval decisions are conditioned by the nature of the medicines and the characteristics of their class. Different degrees of benefits and risks underpinning the decisions have been identified together with the consequent guiding principles that lead to the EMA decision process. A latent general “safety” factor at the basis of EMA decision process was assessed.