Commenting on today’s vote on the EU Clinical Trials Regulation, Esteban Herrero-Martinez, Head of Regulatory Affairs at the ABPI, said: “The ABPI welcomes the European Parliament’s decision in today’s plenary vote towards the adoption of the new Clinical Trials Regulation."

 

​Esteban continued:

“Clinical research drives academic excellence, creates jobs in Europe and facilitates patients’ access to innovative medicines. The new legislative framework will enable a more efficient and harmonised approach to the authorisation and conduct of clinical trials across the EU Member States.  We anticipate this will improve the attractiveness of Europe as a location for clinical research and enhance our ability to develop innovative medicines that benefit patients.

“The ABPI also welcomes the adoption of new transparency requirements for the disclosure of clinical trial information. We commend the progress all parties have made in reaching an agreed European position, which also reflects a commitment to the protection of personal patient data and commercially confidential information.

“We are confident that the agreed text represents a significant step forward in achieving the original aims of this legislative revision, although successful implementation depends on appropriate Member State engagement and the development of the relevant IT infrastructure by the European Medicines Agency, including a European clinical trial database.  The ABPI request continued engagement with all relevant stakeholder groups during the implementation period.”

 

Media enquiries

ABPI Press Office

Tel: +44 (0) 20 7747 1410 or +44 (0) 20 7747 1441
Mobile: +44 (0) 7850 312064 or +44 (0) 7808 641811 Email: pressoffice@abpi.org.uk

Notes to editors

The ABPI represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.

Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. Our members supply 90 per cent of all medicines used by the NHS, and are researching and developing over two-thirds of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome diseases.

The ABPI is recognised by Government as the industry body negotiating on behalf of the branded pharmaceutical industry, for statutory consultation requirements including the pricing scheme for medicines in the UK.

 
 
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