European Commission publishes new documents regarding the Clinical Trials Regulation December 10, 2019
Use of ethanol in medicinal products: European Medicines Agency publishes guidance concerning safety information for the package leaflet December 2, 2019
European Commission provides clarification regarding the implementation of the Clinical Trials Regulation November 18, 2019
What the European Medicines Agency’s qualification opinion means for electronic clinical data capture October 14, 2019
Publication of further guidance on the role of the “UK Responsible Person” in case of no-deal Brexit October 1, 2019
New MDCG Guidance on Summary of Safety and Clinical Performance under the Medical Devices Regulation (MDR) September 30, 2019
Publication of rules on designation of expert panels under the Medical Devices Regulations September 13, 2019