Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Benefit-Risk Assessment of Human Medicines - A Comparison of EMA’s and FDA’s Approach ***

Julia Richnow (Abschlußjahr: 2017)

Summary
Language: Englisch
The assessment of a medicinal product, which evaluates the product’s benefits and risks is the fundamental basis of drug approval decisions. The thalidomide disaster in the 1960’s was a key driver for the establishment of modern regulatory systems, and paved the way for the introduction of benefit-risk assessment in the drug approval process. However, it is a phenomenon of the past decade that regulatory authorities, pharmaceutical industry and academia have turned their focus on methods to facilitate the benefit-risk assessment of medicines.
In recent years, various approaches, ranging from descriptive textual to decision-analytic, quantitative methods have emerged to support the analysis and transparency of a drug’s benefit-risk assessment. This thesis focuses on the benefit-risk initiatives of the European Medicines Agency and the U.S. Food and Drug Administration. These regulatory authorities are under increased pressure to convey their decisions explicitly and understandable. The intention of this thesis is to compare EMA’s and FDA’s benefit-risk assessment approaches and to analyse how these authorities communicate their decisions in the respective assessment reports of selected drugs.
As a result of their initiatives, the FDA adopted a qualitative approach, while the EMA proposed a graduated methodology including quantitative methods for intricate decisions. However, quantitative methods are currently not implemented in EMA’s regulatory practice and it remains unclear whether the EMA will incorporate such methods within the drug approval process in the future. The analysis of the assessment reports revealed that EMA’s as well as FDA’s initiatives have led to more structured benefit-risk evaluations in the respective assessment reports. Although, the FDA and the EMA determined similar key decision factors that drive the decision, the discussion of a drug’s benefit-risk balance may differ greatly.
Pages: 52
Annexes: Pages: 42