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Emilija Berzanskaite
10th January 2022
Consumer, Health & Environment

Regulation setting out cooperation framework between Member States in safety assessment of clinical trials published

Official publication has been made of Commission Implementing Regulation 2022/20 laying down rules of the application of Regulation 536/2014 as regards setting up the rules and procedures for the cooperation of the Member States in the safety assessment of clinical trials.

Regulation 536/2014 lays down the legal framework for clinical trials on medicinal products for human use in the Union. The overall responsibility for ensuring participants’ safety lies with the sponsor of the clinical trial, but additional oversight from the Member States is required through their cooperation in the assessment of the safety of the investigational medicinal products. 

That Regulation also provides that the sponsor is to report suspected unexpected serious adverse reactions to investigational medicinal products used in the clinical trial and to submit annually safety reports to the European Medicines Agency, which are then forwarded to the Member States concerned who then cooperate in the assessment of that information.

The newly published Implementing Regulation 2022/20 sets out a framework for the cooperation between the Member States in the assessment of information and reports, and increases scrutiny in safety oversight in the EU. In particular, the Implementing Regulation sets out the division of workload between the Member States for the safety assessment and a methodology for screening the safety information.

The overarching aim of the Implementing Regulation is to strengthen participants’ safety in clinical trials and contribute to improved data robustness regarding the safety profile of investigational medicinal products and their corresponding active substances.

Read officially published Implementing Regulation 2022/20 here.


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