The aim of regulation in drug safety is to state as clearly as possible and to enforce the legal responsibility of the involved parties (regulators, marketing authorization holders and health care professionals where applicable), and to provide guidance on how the respective duties should be complied with. The guidelines issued have as a significant impact on the outcome as the law itself, as they determine the stakeholders’ compliance and performance.
CITATION STYLE
Caduff-Janosa, P. (2016). Lost in regulation. In Pharmacovigilance: Critique and Ways Forward (pp. 9–19). Springer International Publishing. https://doi.org/10.1007/978-3-319-40400-4_2
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