EuropaBio welcomes the eagerly anticipated Revision of the Clinical Trials Directive, published by the European Commission today.  This is a particularly timely subject for the healthcare biotechnology industry as currently there are more than 650 biotechnology medicines in clinical development.  Clinical trials are essential to the research and development of new and innovative medicines and are conducted to ensure that medicines have favourable benefit-risk, ensuring that they are safe and effective for patients to use.  The speed at which these innovative medicines reach patients is also of crucial importance to the European healthcare system.

The dossier, which is pioneered by Commissioner for Health and Consumer Policy John Dalli, sees for the first time, efforts from the Commission to streamline and harmonise the Clinical Trials process.  The creation of a single ‘EU Portal’ for submission of an application free of charge as well as the introduction of a common standardised format of the clinical trial application, are extremely positive developments that will be of benefit to all stakeholders, translating into reduced administrative burden and costs for public and private sector researchers that will result in faster access to innovative treatments for patients.

EuropaBio also supports the Commission proposal to introduce a ‘reporting Member State’ for multi-national trials.  This Member State will have overall responsibility for the assessment of an application as well as centralising requests for additional information. Many clinical trials take place in numerous locations throughout Europe; therefore it is essential that extending clinical trials to multiple Member States does not trigger a costly and burdensome repetition of the scientific assessments by the different regulatory jurisdictions.

Nathalie Moll, Secretary General of EuropaBio stated: “Last December EuropaBio held an open stakeholder consultation at the European Parliament to debate the Clinical Trials framework in Europe.  We are really pleased see that many of the proposals that were outlined by the experts present - which included patient groups, industry, academia, regulatory agencies, ethics committees and EU institutions - were published in the Commission Proposal.  A common standardised format and harmonised content of the Clinical Trial Application is needed across all EU Member States.  There should be a single pan-European assessment leading to a single pan-European outcome.  The way in which these different provisions are implemented will be crucial, not only to our industry but also the health and well-being of EU citizens. We particularly need to examine in greater detail provisions around safety reporting and risk proportionality. We look forward to collaborating with the European Council and members of the European Parliament so that the proposed regulation provides the best possible outcome for patients across Europe.”

~ENDS~

To view the European Commission Press release, click here

For more information on Clinical Trials in Europe, click here

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 56 corporate members, 11 associate members, 3 BioRegions and 19 National Biotechnology Associations- representing some 1800 small and medium sized enterprises.

For further information, please contact:

Rosalind Travers

Communications & National Associations officer, EuropaBio

Phone: +32 (0) 2 739 1173

GSM: +32 (0) 478 680 301

r.travers@europabio.org

OR

Nathalie Moll,

Secretary General EuropaBio

Phone: +32 (0) 2 739 1171

n.moll@europabio.org