BioIndustry Association Welcomes Publication of Proposed EU Regulation on Clinical Trials

Published: Jul 17, 2012

17 July 2012 -- The BioIndustry Association welcomes the legislative proposal for a Regulation on clinical trials presented by the European Commission today.

A simplified and efficient regulatory framework for clinical trials is vital to improve Europe's attractiveness as a global location for clinical research and development of new medicines. This will benefit all stakeholders in the European Union, allowing patients faster access to innovative treatments, whilst reducing the administrative burden and costs for public and private sector researchers as well as for EU Member States.

The proposed Regulation will introduce:

• A single submission of a harmonised clinical trial application dossier through a single EU portal;

• A streamlined authorisation process for a clinical trial - whether for an initial application, for a second wave of clinical trial application to extend the trial to additional Member States or for a substantial modification of the trial;

• Strong cooperation among Member States with a 'Reporting Member State' to lead a pan-European assessment on regulatory and scientific aspects of the application dossier; and

• A single decision per Member State encompassing both the regulatory and ethical/local aspects of a clinical trial assessment.

Alan Morrison, Chair of the BIA Regulatory Affairs Advisory Committee, said:

"The BIA is delighted that the European Commission has adopted this legislative proposal for a Regulation on clinical trials which should lead to more harmonisation, transparency and consistency in the approval and conduct of clinical trials across EU Member States, while maintaining high standards of patient safety and robustness and reliability of clinical data.

"The BIA has been highly engaged over the last few years to get to this point. We have had regular communication with the Commission and participated in stakeholder meetings, alongside EuropaBio, we responded to the Commission's consultations and we presented the life sciences industry's messages to Members of the European Parliament. I am pleased to see that the Commission has addressed a number of our key concerns in the proposal.

"The BIA looks forward to engaging with the European Parliament and Council, as this legislation proceeds through the co-decision procedure, and calls on them both to expedite this process to ensure a supportive clinical research environment in Europe."

Steve Bates, BIA Chief Executive Officer, said:

"The proposed Regulation will save time, money and paperwork for companies wishing to run clinical trials across Europe, thus making it easier to develop innovative medicines for patients."

"The BIA continues to work with government, the Medicines and Healthcare products Regulatory Agency, key stakeholders in research and the NHS to help deliver the Strategy for UK Life Sciences, by ensuring that regulation keeps pace with innovation.

"Finally, I would like to thank our member companies that have contributed to the work the BIA, led by Christiane Abouzeid, our Head of Regulatory Affairs, has done on this topic over the past six years. The regulation of clinical trials has been a key regulatory priority for the BIA for many years and will remain so in future. Through Christiane, the BIA has also taken a leadership role on clinical trials for EuropaBio, the European Association for Bioindustries.

For further information, please contact Robert Winder, Head of Communications,, 020 7630 2191; mobile 07825 942 934.

The European Commission legislative proposal for a Regulation on clinical trials for medicinal products: . Once adopted by the European Parliament and Council this Regulation will be binding and applicable in all EU Member States and will not need to be transposed into national laws.

The last BIA consultation response prepared in partnership with EuropaBio providing the views of our members in response to the questions posed in the concept paper on the revision of the Clinical Trials Directive 2001/20/EC:

BIA-EuropaBio key message on the revision of the Clinical Trials Directive 2001/20/EC:

BioIndustry Association

Founded over 20 years ago at the infancy of biotechnology, the BioIndustry Association (BIA) is the trade association for innovative enterprises involved in UK bioscience. Members include emerging and more established bioscience companies; pharmaceutical companies; academic, research and philanthropic organisations; and service providers to the bioscience sector. The BIA represents the interests of its members to a broad section of stakeholders, from government and regulators to patient groups and the media. Our goal is to secure the UK's position as a global hub and as the best location for innovative research and commercialisation, enabling our world-leading research base to deliver healthcare solutions that can truly make a difference to people's lives. For further information, please go to

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