Impact on regulatory Framework for Clinical Trial Applications within the European Union from Voisin Consulting Life Sciences
The current regulatory framework for Clinical Trials in the EU is the Clinical Trial Directive 2001/20/EC (CTD) which entered into force in 2004. The CTD objective was to provide reliability and robustness of CT while ensuring respect of the rights, safety, dignity and well-being of subjects (these prevailing over all other interests). In 2004, a Clinical Trials Facilitation Group (CTFG) was established to coordinate the implementation of the EU CTD. CTFG also promotes a better harmonization of clinical trial assessment decisions and administrative processes across the national competent authorities (NCAs), through the development of the Voluntary Harmonization Procedure (VHP).
The objectives of this new CTR are similar to those from CTD, it also aims at increasing transparency, keeping the balance between protecting public health and fostering the innovation capacity of European medical research.
The CTR will bring significant improvements to current CTA processes and is also introducing a risk adapted approach and we need to start now preparing for being ready for these changes.