Major report reveals problems with EU Clinical Trials Directive
This article was originally published in SRA
The European Clinical Trials Directive, which came into force in 2004 with the goal of harmonising the clinical research environment throughout the European Union, has made it more complicated for sponsors to conduct multinational clinical trials. It has also increased the administrative burden for competent authorities evaluating and supervising clinical trial authorisations. These are just two of many findings from a major EU-sponsored project set up to examine how the directive (2001/20/EC) has affected pharmaceutical research in the EU1,2.
You may also be interested in...
New medicines under evaluation at the European Medicines Agency.
The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with seven new products including Roche's Polivy for treating diffuse large B-cell lymphoma. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).
A number of new products have been submitted for review at the European Medicines Agency. While marketing authorization applications from ViiV Healthcare and BioMarin Pharmaceutical are being fast-tracked, a submission from Incyte is not.