Already since 31 January 2023 all applications for new clinical trials must be submitted under the legal framework of the Clinical Trials Regulation (Regulation EU/536/2014, CT Regulation).

A European Union (EU) ruling moving clinical trials across the continent onto a single platform, the Clinical Trials Information System (CTIS), has come into full effect with ‘corrective ...

EU Clinical Trials Regulation (EU CTR) has been a hot topic for a little while now. An initiative launched by the European Commission, EMA, and national regulators within the EU in 2022 in order ...

European Union lawmakers designed EU Clinical Trial Regulation 536/2014 to heighten interest within the healthcare industry for planning and conducting clinical trials in the EU, which experienced ...

A major overhaul and consolidation of EU clinical trial regulations is paving the way to faster approvals, greater international coordination, and resilience to drug shortages, according to ...

"As we operate under the EU Clinical Trials Regulation, we encourage Belgium to work with other EU Member States and relevant stakeholders to ensure that the operation of the Regulation delivers ...