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The EU intends to simplify the rules for conducting clinical trials
Last reviewed: 01.07.2025
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In early July 2012, the head of the EU announced his intention to introduce new rules the following week that would significantly simplify the regulation of clinical trials conducted by pharmaceutical companies and scientists in various EU member states. The aim of this innovation is to reduce costs and bureaucratic delays in conducting them.
European Commission officials noted that the number of clinical trials conducted in the EU has fallen by 15% in recent years, while the costs of conducting them and the length of bureaucratic delays have doubled.
Researchers attribute the increase in the cost and time required to complete the paperwork to the adoption in 2001 of new rules designed to introduce stricter controls over the monitoring and reporting of clinical trials of drugs in the EU in order to improve patient safety.
Under current rules, companies and researchers wishing to conduct clinical trials in more than one EU member state must submit separate applications for authorisation in each of those countries.
John Dalli, the European Commissioner for Health and Consumer Policy, said the new rules, due to be presented on 17 July, would aim to create a harmonised system for conducting clinical trials in the EU. This would mean that in order to conduct trials in several EU member states, it would be sufficient to apply for authorisation for such activities only once.
The ability to conduct clinical trials in several countries is particularly important for the development of drugs for rare diseases, as the number of patients living in one country is often insufficient to carry them out. According to the European Commission, about 25% of all clinical trials conducted in the EU involve patients from 3-5 countries.
Once published, the new rules must be agreed upon by the national governments of EU member states and the European Parliament. This procedure can take up to 2 years.
According to Peter Liese, a member of the German parliament, the current rules for conducting clinical trials have encouraged them to be moved to other countries, such as India, where the costs are significantly lower. According to the current rules, clinical trials conducted outside the EU must be carried out according to standards equivalent to those adopted in the EU. Only then can their results form the basis for approval of a medicine in the EU.