5th April 2014

New rules for clinical trials

On 2 April, the European Parliament adopted new rules for clinical trials. The new regulation repeals the now-in-force directive and addresses its shortcomings. Under the new rules, pharmaceutical companies and researchers will be obliged to make their research results publicly accessible. This should provide for better cross-control. Furthermore, the regulation improves cross-border cooperation possibilities inside the EU. The proposal´s rapporteur Glenis Willmott stated, that there is simply not enough patients in any of EU countries to run a truly successful clinical trial. Cross-border cooperation is therefore necessary. The new regulation provides unified rules on EU level, thus potentially making cross-border trials more effective. The regulation further simplifies the procedures and provides the European Commission with oversight powers. In order for the regulation to come into force, it will have to be adopted also by the Council.

For more, click here.

Members of the American Chamber of Commerce in the Czech Republic