Safety Reporting for Auxiliary Medicinal Products in the Sibeprenlimab Phase-III Study According to the New European Union (536/2014) CT Regulation.
Sign Up to like & getrecommendations! Published in 2025 at "Current drug safety"
DOI: 10.2174/0115748863329287250411114336
Abstract: BACKGROUND The new European Union clinical trials regulation (EU CTR 536/2014) became effective on 31 January 2022. It introduced the novel concept of Auxiliary Medicinal Products (AxMPs) to be implemented in clinical trials in Europe.… read more here.
Keywords: auxiliary medicinal; european union; 536 2014; safety ... See more keywords