The EU intends to simplify the rules for conducting clinical trials
Last reviewed: 16.10.2021
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In early July 2012, the head of the EU announced the intention to submit next week new regulations that significantly simplify the regulation of clinical research by pharmaceutical companies and scientists in various EU member countries. The purpose of this innovation is to reduce costs and bureaucratic delays in their conduct.
Representatives of the European Commission noted that the number of clinical studies conducted in the EU has declined by 15% over the past few years, while spending on them, as well as the length of bureaucratic delays, has doubled.
Researchers associate the increase in financial and time costs required for documenting with the adoption in 2001 of new regulations designed to introduce more stringent monitoring and reporting controls for clinical trials of medicines in the EU in order to improve patient safety.
According to the current rules, companies and researchers wishing to conduct clinical trials in more than one EU member state are compelled to file separate applications for authorization in each of these countries.
John Dalli, European Commissioner for Health and Consumer Policy, noted that the new rules, due on July 17, will be aimed at creating a harmonized system for conducting clinical trials in the EU. Thus, to conduct research in several EU member states it will be sufficient to file documents for obtaining a permit for such activities only once.
The possibility of conducting clinical trials in several countries is particularly important in terms of developing drugs for the treatment of rare diseases, since often the number of patients living in one country is not sufficient for their implementation. According to the European Commission, about 25% of all clinical trials conducted in the EU include patients from 3-5 countries.
After publication, the new rules should be agreed with the national governments of the EU member states and the European Parliament. This procedure can take up to 2 years.
According to Peter Liese, member of the German parliament, the current rules for conducting clinical trials have facilitated the transfer of those to other countries, for example, India, where the cost of conducting them is much lower. According to the current rules, clinical studies carried out outside the EU should be conducted in accordance with standards equivalent to those adopted in the EU. Only in this case their results can become the basis for the approval of the medicinal product in the EU.