On 31 January 2022, the long-anticipated EU Clinical Trials Regulation (CTR) will become applicable (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32014R0536). The CTR aims to standardize and harmonize the conduct and management of interventional clinical trials across the EU/EEA. The backbone of the changes brought about by the CTR is the new Clinical Trials Information System (CTIS). CTIS essentially serves as a one-stop, centralised database for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data. This should make authorization and patient recruitment for multinational clinical trials much easier too. Note that members of the public with have enhanced access to clinical trial data through CTIS.
The CTR contains loads of detailed provisions and more implementing rules and guidance are expected. There is a steep learning curve, and as a matter of priority, sponsors should start reviewing their current and planned clinical trial portfolios and see how these fit within the complex transitional provisions of the CTR.
Whilst the CTR is seen as the EU’s opportunity to put Europe back on the map as a world-leading research environment, the UK (even though of course the CTR does not apply in its territory) is also keen to keep its position as a global leader in running clinical trials and getting innovations to patients. To that end, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation on 17 January 2022 on the future of UK clinical trials legislation (https://www.gov.uk/government/consultations/consultation-on-proposals-for-legislative-changes-for-clinical-trials).