EC proposes to simplify clinical trial authorizations

The European Commission introduced a proposed regulation that it said would make it easier for sponsors to conduct multinational clinical trials in Europe. The regulation would create a new trial authorization procedure allowing sponsors to submit only one application for a trial across multiple member states, instead of multiple submissions of identical information to each member state. Additionally, the regulation would allow a single member state to be appointed to review an application.

The regulation would replace the Clinical Trials Directive of 2001, which EC said "led to an unfavorable regulatory framework for clinical research" and contributed to a decrease of 25% of clinical trials conducted in the EU from 2007-11. In 2007, sponsors applied for more than 5,000 clinical trials in the EU, compared to about 3,800 in 2011, according to the commission. The proposal will be discussed in the European Parliament and in the Council. It is expected to take effect in 2016. ...