January 31, 2022, was a landmark in the history of clinical trials in Europe! Finally, the new Regulation 536/2014 was implemented in the 27 countries of the European Union!
Countries of the European Union already had common legislation for clinical trials, the Directive 2001/20, which failed in the harmonization process as many countries modified it according to National procedures. Regulation 536/2014 cannot be changed at a national level, so the harmonization of processes will be guaranteed. The figure 2014 indicates the year of approval: Implementation of the regulation took eight years: why so long? Initially, we were told that the digital platform was very complex and required time to be finalized. Then rumors arose that several countries, especially the smallest ones like Malta which has only half a million inhabitants, asked for more time to educate the experts who were going to evaluate the IND applications and therefore get a European responsibility. But what are the most important innovations of Regulation 536/2014? They are mainly two: a unique portal for all EU applications, so sponsors do not need any longer to apply for a clinical trial in every EU country. Second, the application will be evaluated by only one country (and in parallel by both the Competent Authority and one Ethics Committee). This single evaluation will then be accepted by all other EU countries.
Additional important novelties are the commitment to reach a final decision within 90 days (and we all know how important time is in our drug development plan) and the identification of “low risk trials,” namely the Phase IV studies, which will benefit a faster approval process. Hopes are that these changes will stimulate the activation of more clinical trials in Europe, which in fact, in the last decade declined from 7000 per year to about 5000 per year (EMA data). For more details, please refer to
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