The implementation of the European Medical Device Regulation, Regulation (EU) 2017/745 (MDR) and the publication of numerous guidelines could increase the already existing confusion about the association of medicinal product or medicinal substance with medical device. The objective of this…
"During the summer 2018, authorities become aware of the presence of some nitrosamines in API – (Valsartan – presence of N- nitrosodimethylamine (NDMA) - other sartans – presence of N-nitrosodiethylamine NDEA). These nitrosamines were already known as probable carcinogenic compounds…
Advanced Therapy Medicinal Products are innovative and complex medicinal products for which successful development requires a good understanding of the applicable regulatory requirements. This WhitePaper on Advanced Therapy Medicinal Products (ATMP) in Europe, adapted from the article published…
Clinical Trials (CT) are currently regulated under the Directive 2001/20/EC. The Directive had a positive impact on the safety, ethic and reliability of data from CT. However, limitations were soon evidenced such as a decreased number of CT in…
