EuropaBio welcomes the launch of the EU Clinical Trials Register

23.03.2011

Brussels, 23 March 2011

Yesterday, the European Medicines Agency (EMA) and the European Commission announced the launch of the EU Clinical Trials Register (EU-CTR). The register will, for the first time, allow public access to information on interventional trials for medicines authorised in the 27 EU Member States as well as Iceland, Liechtenstein and Norway.

Compiling information drawn from the EU clinical trials database (EudraCT), the EU-CTR is a unique repository of up-to-date information on clinical trials allowing patients and healthcare professionals easy access to key information on the latest opportunities offered by clinical researchconducted by both industry and research institutions.  The comprehensive functionalities of this new register will help the public find clinical trials by countries, age, gender, trials phase and status.

Commenting on the launch, Dr Christiane Abouzeid, Head of Regulatory Affairs at BioIndustry Association (BIA) and Topic Leader of the Clinical Trials Group at EuropaBio said “This is a major step towards the development of a database of clinical trials easily accessible to patients, their families and healthcare professionals. Such registers exist in other regions of the world, such as the US, and over the years they have also proven very useful in avoiding unnecessary duplication of clinical trials.”

Nathalie Moll, EuropaBio Secretary General also commented “EuropaBio warmly welcomes the launch of the EU-CTR. As of yesterday, crucial information on trials for innovative and potentially life-saving therapies are now available, bringing renewed hope to patients. It also marks a clear move toward further transparency in the field of medical research across Europe.”

According to data from EudraCT, every year more than 4000 clinical trials are performed in the EU/EEA, involving about 400 000 patients. Roughly 25% of EU clinical trials are performed in more than one EU Member State. Information for trials conducted outside Europe, as part of a Paediatric Investigation Plan, is also available via EU-CTR.

Additional resources

  • To access the EU ClinicalTrials Register, please click here
  • To download a copy of the EMA’s press release “EU Clinical Trials Register goes live”, pleaseclick here
  • To download a copy of the European Commission’s press release “Pharmaceuticals: today, the EU Register of Clinical Trials is launched online”, please click here
  • To download a copy of EuropaBio’s position paper read “Europe requires a modern regulatory framework for clinical trials now”, please click here

For further information please contact:

Ludovic Lacaine
Healthcare Biotech Director, EuropaBio
l.lacaine@europabio.org
T: +32 2 739 11 83

Joanna Dupont-Inglis
Communications Manager, EuropaBio
j.dupont@europabio.org
T: +32 2 739 11 84; GSM: +32 476 60 71 35


About EuropaBio

EuropaBio is the European Association for Bioindustries, bringing together bioscience companies from all fields of research and development, testing, manufacturing and distribution of biotechnology products. It has 66 corporate and 7 associated members, 4 BioRegions and 22 National Biotechnology Associations representing some 1800 small and medium sized enterprises.www.europabio.org