Biotech industries still see room for improvement in Clinical Trials Directive

The European Association for Bioindustries, EuropaBio, has repeated its call for the review of the EU’s Clinical Trials Directive and its implementation into national laws. Following a joint
conference organised by the European Commission and the European Medicines Agency (EMEA), EuropaBio states that the directive fails to bring the necessary harmonisation across Member States.

The joint conference on the ‘Operation of the Clinical Trials Directive (Directive 2001/20/EC) and perspectives for the future’ led to a broad understanding of the issues and helped to identify
hurdles making Europe less attractive for clinical trials, EuropaBio says. However, in order to develop a harmonised approach to the approval and conduct of clinical trials across Europe,
provisions and definitions, for instance, of investigational medicinal products need to be better specified.

Moreover, EuropaBio members think that a single submission point for clinical trials applications (CTAs) should be established as well as a centralised reporting system. The role and
responsibilities of ethical committees at local and national level also have to be streamlined, the industry association adds.

EuropaBio generally sees the need for strengthening the remit of the Clinical Trial Facilitation Group (CTFG). At the same time, the EMEA should support and coordinate the CTFG as well as
contribute to the mutual recognition of assessments carried out by National Competent Authorities (NCAs). Finally, the biotechnology industry calls for a similar approach to be taken to cover
clinical trial developments for the new generations of therapies and products covered by the Advanced Therapies Regulation.

While all of these points have to be addressed by the current legislative framework, EuropaBio says, changes have to be made gradually.

‘We strongly believe in a step-wise approach to ensure stability and continuity in the legislative framework for clinical trials on innovative medicines in Europe while at the same time
allowing the introduction of corrective actions which are urgently needed to ensure that Europe retains its strength, its leadership and its excellence in Good Clinical Practices,’ Andrea
Rappagliosi, Chairman of EuropaBio’s Healthcare Council, explains.

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