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

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

Roberta Troisi (University of Salerno, Salerno, Italy) and Carmine Garzillo (University on Naples “Federico II”, Naples, Italy)
DOI: 10.4018/IJPPHME.2015010101
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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.
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Materials And Methods

The EMA Framework

By checking EMA website, the public assessments about human medicines have been analyzed. We limited our investigation to human medicines that were submitted for approval in the past five years, accepting the EMA criteria of classification1. Terms like i) efficacy, ii) efficiency, iii) effectiveness, for example, were used with their general meanings, respectively i) reproducing an effect consistently, ii) measuring the performance of the process of conversion of inputs into outputs, iii) measuring the degree to which the outputs satisfy requirements.

Three hundred and fifteen medicines were classified in different therapeutic groups according to the organ or system on which they act. The classification was arranged on the anatomical groupings which ATC Code2 takes into account. In this way we have considered 14 groups: 1) Alimentary tract and metabolism, 2) Blood and forming organs, 3) Cardiovascular system, 4) Dermatological, 5) Genitourinary system and sex hormones, 6) Systemic hormonal preparations excluding sex hormones and insulins, 7) Anti-infective for systemic use, 8) Antineoplastic, 9) Musculoskeletal system, 10) Nervous system, 11) Anti-parasitic, 12) Respiratory system, 13) Sensory organs, and 14) Others not classified.

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