• Press Office

    Posted in category ABPI statement by Press Office on 20/12/2013

    Agreement reached by the European institutions on the text of a new EU Clinical Trial Regulation

After detailed negotiation by the European Union institutions (the European Parliament and Council), a compromise agreement has been reached on the text of this legislation and it now looks likely that it will be adopted in early 2014. It is estimated to come into force two years after the adoption date.

 

​Commenting on this agreement, Esteban Herrero-Martinez, Head of Regulatory Affairs said:

“Clinical research drives academic excellence, creates jobs in Europe and facilitates European patients’ access to innovative medicines. We support the aims of revising the European clinical trial legislation, which were to improve the attractiveness of Europe as a location for clinical research by reducing unnecessary red tape and ensuring a harmonised approach in the EU Member States, whilst preserving or improving the quality and safety of clinical trials.

“There are elements of this legislation which will positively impact the European environment for clinical research. These include a single submission of data for clinical trial authorisations, a coordinated process to obtain these authorisations with an opinion per Member State,  and ensuring a harmonised approach across the European Union by revising the original Directive as a Regulation. 

“The ABPI was strongly supportive of the European Commission’s competitive timelines for the clinical trial authorisation process, as these would decrease cost and make Europe more competitive, and we are disappointed at the significant lengthening in the compromise text.  Despite this, we are confident that the agreed text overall represents a significant step forward in achieving the original aims of this legislative revision.

“The draft Regulation also includes new transparency requirements for the disclosure of clinical trial information. We welcome the progress achieved by all parties in reaching an agreed European-wide approach for the disclosure of clinical trial information and the legislator’s approach to the protection of personal patient data and commercially confidential information.”

 

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Notes to editor

Key to note is the additional industry commitment to this issue captured in the EFPIA-PhRMA principles for responsible data sharing with researchers, patients and the general public. The ABPI will continue to keep a close watch on the EU Clinical Trial Regulation as it proceeds to the next stage in the legislative process.

About the ABPI

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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