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Commission proposes to revamp rules on clinical trials

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The European Commission has adopted a proposal to boost clinical research in Europe by simplifying the rules for conducting clinical trials. The new legislation will take the form of a regulation. This will ensure that the rules for conducting clinical trials are identical throughout the EU. In particular, it will make it easier to conduct multinational clinical trials in Europe. It will include an authorisation procedure for clinical trials which will allow for a fast and thorough assessment of the application by all Member States concerned and which will ensure one single assessment outcome, simplified reporting procedures, more transparency on participant’s recruitment, as well as a possibility for the Commission to conduct controls in Member States and other countries to make sure the rules are being properly supervised and enforced. The legislative proposal will now be discussed in the European Parliament and in the Council. It is expected to come into effect in 2016. For further information, please visit EC website.

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