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Innovation Is Not Always Fast: EU Clinical Trials Regulation Goes Live 10 Years After Publication
Thomas Kühler

anuary 31, 2022, marked a very important day in European Union (EU) pharmaceutical regulation history. After some 10 years in the making, the EU Clinical Trials Information System (CTIS) went live per the European Commission (EC) decision 2021/1240. With the launch of the CTIS, the Clinical Trials Regulation (CTR) 536/2014, proposed in 2012 to replace the Clinical Trials Directive (CTD) 2001/20/EC, officially became applicable.

Many vested parties were involved in developing the CTIS portal, including clinical trial sponsors, national competent authorities and their respective ethics committees, the European Medicines Agency (EMA), and the EC, to name only a few, and the CTR was delayed several times because of problems with accommodating end-user design and technical specifications in the development of the portal.

The CTIS portal provides a “one-stop shop” for submitting clinical trial applications (CTAs) and a common workspace for regulators to review and authorize them. It brings regulatory bodies from some 30 countries in the EU and the European Economic Area together to furnish one single decision.

For a transition period of 12 months, until January 31, 2023, sponsors can choose whether to submit their CTAs through the CTIS or under the previous CTD framework. After that date, it will be mandatory to file new applications through the new CTIS portal; by January 31, 2025, all approved and ongoing trials must have been moved into the CTIS.

Transitioning away from a system that requires multiple CTA filings and individual assessments by several Member States into a single consolidated decision and review system constitutes a landmark moment for the conduct of clinical research in the EU. The new CTR propels the EU to the forefront of clinical trial (CT) conduct and ensures that it remains a competitive place to conduct clinical research for the benefit of patients and society.

Transparency, which is always high on the EU clinical research agenda, is also prominent in the scope of the new CTR. A searchable website that provides detailed information on CTs and is open to patients, healthcare professionals, and the general public was launched in connection with the introduction of the CTIS. Such information as trial sponsor affiliation, various start and end dates, principal investigator, outcome of the trial, etc., will be made publicly available. According to the EMA, information including but not limited to the identity of the investigational medicine and details on the trial design will also be made available, but its publication may be deferred to protect legitimate intellectual property or other economic interests.

Sponsors can register as a CTIS user and log in to the system through the Clinical Trials website. Clicking the “CTIS for sponsors” tab on the Clinical Trials website opens up the sponsors’ workspace in the CTIS and guides sponsors and others involved in the trial to prepare their CTAs. Prospective sponsors will also benefit from the following resources: A User Access Management Quick guide, a CTIS online modular training program, and a CTIS Sponsor Handbook.

I like to believe that the “go live” of the CTR will reinvigorate and catalyze clinical research in Europe and hopefully will render patients prompt access to novel therapeutics and innovative treatments.

In closing (an intended pun) and to loop back and close the circle with this article’s title: Innovation may not always be fast paced, but life certainly is. Indeed, I have reached the age of retirement and this article constitutes the closing of my tenure as Global Forum Regional Editor for Europe. Thanks for reading.