Clinical trials are defined by EMA as “studies performed to investigate the safety or efficacy of a medicine. For human medicines, these studies are carried out in human volunteers”. In the field of advanced therapies, clinical trials are usually the last step of a very long preclinical research phase that can last for decades. Unfortunately, the bureaucratic steps required, and all the regulation procedures often act as a bottleneck in the development of new innovative drugs.
To overcome these difficulties, EMA has recently developed a new regulation system, called Clinical Trials Regulation, aiming to harmonize the process for assessment and supervision of clinical trials throughout the European Union.
The ultimate goal of this new regulation form is to improve and encourage the carry out of clinical trials on a large scale, increasing, at the same time the standards of public transparency and safety for participants.
The most important update regards the institution of an online platform used to submit a new application, named Clinical Trials Information System (CTIS). Before CTIS, the submission of clinical trials had to be parallel between national competent authorities and ethics committees of each country, with all the administrative difficulties that you can imagine. The new platform makes everything more efficient, allowing, at the same time, an easily carrying out of multinational trials.
Other important updates of CTIS includes:
– The submission, with one single application, a clinical trial request in up to 30 European countries;
– The speed up the expansion of clinical trials on other EEA countries;
– An increased transparency and information access through an online public website.
Even if the Clinical Trials Regulation entered into application on 31 January 2022, a transition period has been planned, allowing the sponsor to better understand the directives. A new application will be able to be submitted both on CTIS or under the previous Clinical Trials Directive until 30 January 2023. CTIS will become the only procedure to submit a clinical trial from 31 January 2025.