In the last decades, the evolution of new technologies contributed to the development and implementation of the new regulatory framework on which Medical Devices Regulation (MDR) and In Vitro...
Digital health technologies (DHT) can be deployed over a broad range of use in healthcare. This entails different approaches in their regulation and the assessment of their benefits, risks,...
A very important result from the EUPATI project was the development, broad consultation and final release of guidances on the best approach to interaction of patients with pharmaceutical industry-led...
This article explores patient involvement in scientific regulatory committees in the EU, specifically in the activities of the European Medicines Association (EMA).
Before a medicinal product can be marketed and sold, a marketing authorisation must be obtained from the relevent National Competent Authorities. The marketing authorisation application process can take one...
After Phase III of clinical studies, all the information on a medicin is collected and organised in a pre-determiend format (a dossier), which is then submitted to the regulatory...
