The European Commission proposed to reform the European rules to speed up and simplify the authorisation and reporting procedures, while maintaining the highest standards of patient safety and robustness and reliability of data.

According to the European Commission, clinical trials are vital to develop medicines and to improve and compare the use of already authorised medicines. For this reason, it has proposes new rules to speed up and simplify the authorisation and reporting procedures. At the same time, these rules will maintain the highest standards of patient safety and robustness and reliability of data. The measures will also better differentiate the obligations according to the risk-profile of the trial, and improve transparency including on trials done in third countries. In April 2012, some European regulators examined the reasons for and against the open access of the results of clinical trials.

The new Regulation 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. Some concrete proposals are 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, and simplified reporting procedures. More transparency on whether recruitment for participating in a clinical trial is still ongoing, and on the results of the clinical trial is a proposal too.

Thanks to the new measures, the Commission will be able to conduct controls in Member States and other countries to make sure the rules are being properly supervised and enforced. Clinical research with over €20 billion of investment per year in the EU makes a significant contribution to the growth policy of the Europe 2020 agenda. However, it has ensured high level of patient safety, but its divergent transposition and application led to an unfavourable regulatory framework for clinical research, thus contributing to a decrease of 25% of clinical trials conducted in the period between 2007 and 2011.