BMC Medical Ethics
(Accessed 31 Oct 2020)
Ethics and the marketing authorization of pharmaceuticals: what happens to ethical issues discovered post-trial and pre-marketing authorization?
In the EU, clinical assessors, rapporteurs and the Committee for Medicinal Products for Human Use are obliged to assess the ethical aspects of a clinical development program and include major ethical flaws in the marketing authorization deliberation processes. To this date, we know very little about the manner that these regulators put this obligation into action. In this paper, we intend to look into the manner and the extent that ethical issues discovered during inspection have reached the deliberation processes.
Authors: Rosemarie D. L. C. Bernabe, Ghislaine J. M. W. van Thiel, Nancy S. Breekveldt, Christine C. Gispen and Johannes J. M. van Delden
Content type: Research article
27 October 2020