Born with the aim of harmonising the application, evaluation, and supervision process of clinical trials conducted in EU countries, there is much room for improvement for the Clinical Trial Information System CTIS, particularly with regard to SMEs and translational researchers.
In 2016, PharmaMar filed a European marketing authorisation application for Aplidin as a treatment for patients with multiple myeloma. After the European Medicines Agency rejected the MAA twice, which was accepted in Australia with the same data, PharmaMar sued the EC. European Biotechnology spoke with PharmaMar’s Chairman José María Fernández Sousa-Faro.