Traduction de «Biomédicament » (Français → Anglais) :

25. Points out that the fact that there is a plethora of divergent, or at any rate not wholly consistent, national rules applying at every stage from development to the clinical trial is recognised to pose a severe limitation, making it difficult to develop and test new biomedicines on an EU-wide scale, although these are activities that should be encouraged; takes the view, therefore, that, as a first step, the EU directive on clinical trials should be transposed into national law as soon as possible; if the opportunities are exploited to the full, Union citizens will be able to benefit from the significant health advantages of geneti ...[+++]c research, and further investment will gravitate towards European science and the pharmaceutical industry, which are having to operate in an increasingly more competitive global context;

The fact that there is a plethora of divergent, or at any rate not wholly consistent, national rules applying at every stage from development to the clinical trial is recognised to constitute a severe bottleneck making it difficult to develop and test new biomedicines on an EU-wide basis.

27. Believes that a harmonised regulatory framework needs to be established in order to give precedence to the interests of the public, health, and the research community, and to lay down strict and clear-cut rules to govern not only the development, but also testing and approval of new biotechnological drugs and reagents for genetic testing;

set up centralised information and/or common material systems, employing procedures such as registration of data on new biotechnological drugs and genetic testing, including clinical trial data and information connected with the subsequent approval stage (for instance notes on adverse reactions), comparison with pharmacogenomic data (correlating specific genetic features with individual reactions to drugs), or the organisation of patient databanks or the development of central tissue banks;

– if the outcome of the new biomedical research is to be turned to account in a safe, constructive, and responsible way, it will be essential to establish a harmonised regulatory framework, recognised throughout Europe, giving priority to the interests of the public, health, and research communities, and consisting of clear-cut rules to govern not just the development, but also trials and the approval of new biomedicines.

Sorin Biomedica S.p.A., a FIAT subsidiary, will receive an amount of Lit. 2. 625M. in the form of a grant (total intensity of 42.1%) towards the cost of the project.