The European Union has adopted new regulations on clinical trials that will come into force in 2016. Regulation (EU) No. 536/2014 will significantly alter the European clinical trial landscape by replacing national legislation that was harmonized by a European directive with a regulation that is directly applicable in each Member State. This is intended to synchronize the legal environment throughout the EU. In addition, the new regulations provide for a streamlined approval system, setting out defined timelines. It remains to be seen whether the authorities will be able to comply with these. Another important aspect is the publication of clinical trial data, which will allow the sponsor to redact confidential information.
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