After a series of delays, the European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation was released in January. It aims to ensure that the EU offers an “attractive and favorable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants,” the European Medicines Agency says.
The EU repealed the former Clinical Trials Directive (EC) No. 2001/20/EC and national implementing legislation in the EU Member States, which had governed clinical trials in the EU until the new Regulation’s entry into application.
Calling it a “cornerstone” in the EU’s efforts to streamline the clinical trial application process, Norbert Clemens, MD, PhD, CPI, ACRP-PM, ACRP-MDP, FACRP, director of Clinical Trial Management for the EMEA region for HOYA Surgical Optics in Germany, noted the high expectations for the regulation and its affiliated application system were partially behind its delay. “You can now apply to up to 22 EU countries at the same time,” and that’s a huge leap forward, says Clemens, an Association of Clinical Research Professionals (ACRP) Fellow and Chair of the Academy of Clinical Research Professionals, which oversees the various professional certifications available through ACRP.
Prior to the Regulation, trial sponsors had to submit applications separately to the competent authorities and ethics committees in each country to gain regulatory approval to run a clinical trial. However, the new Regulation enables sponsors to submit one online application via a single online platform known as the Clinical Trials Information System (CTIS) for approval to run a trial in several European countries, making it more efficient to carry out such multinational trials, Clemens notes.
The Regulation also makes it more efficient for EU Member States to evaluate and authorize such applications together, via the CTIS. For more information on the Regulation and the CTIS, see this peer-reviewed article from the February 2022 issue of Clinical Researcher, the flagship publication of ACRP.
Author: Michael Causey