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Cortex - Life Sciences Insights

| 1 minute read

Safety assessment of clinical trials in the EU: how will Member States be involved?

The 31st January marked the day both the EU Clinical Trials Regulation (Regulation (EU) No 534/2014 – “CTR”), and the framework for the cooperation of Member States in safety assessment of clinical trials (Commission Implementing Regulation (EU) 2022/20) became applicable.

According to the CTR, sponsors of clinical trials must electronically report all relevant information about suspected unexpected serious adverse reactions in clinical trials performed in at least one Member State, and submit an annual report on the safety of each investigational medicinal product used in a clinical trial for which they are the sponsors.

The information reported by sponsors in accordance with Articles 42 and 43 of the CTR is forwarded by the EMA to the concerned Member States, which shall cooperate in assessing its content.

The now applicable Implementing Regulation sets out the framework for Member State cooperation in the assessment of information and reports, notably setting out rules for dividing the workload between safety assessing Member States and reporting Member States.

Specifically, ensuring a coordinated approach to safety assessment is procured by the determination that a single safety assessing Member State should, whenever possible, assess the safety of all investigational medicinal products containing the same active substance, regardless of pharmaceutical form, strength or indication investigated and regardless of being used in several clinical trials managed by the same or different sponsors.

Implementing Regulation (EU) 2022/20 applies to all active substances that are used in investigational medicinal products in clinical trials authorised in at least two Member States. Mono-national active substances, active substances in investigational medicinal products used as reference products (including as a placebo), and active substances used in auxiliary medicinal products are excluded from its scope.

The CTR introduces a unified regulatory regime that will apply across the EU, with the goals of re-establishing the EU’s competitiveness in the field of scientific research and innovation, ensuring that clinical trial data are reliable and robust, and maintaining high standards of patient safety.


clinical trials, europe, regulation-pharma