Clinical Trials Regulation - Cooperation of Member States in Safety Assessment of Clinical Trials
The European Commission published yesterday a Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 “laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials” (the Regulation; see, attached copy).
Giving effect to Article 44(2) of the Clinical Trials Regulation (CTR), the Regulation lays down rules for the cooperation between EU Member States in the assessment of information and reports submitted by clinical trial sponsors under Articles 42 and 43 CTR. Article 42 CTR concerns the sponsor’s obligation to report suspected unexpected serious adverse reactions to the European Medicines Agency (EMA). Article 43 CTR, in turn, requires clinical trial sponsors to submit to EMA annual reports on the safety of each investigational medicinal product (other than placebo) used in trials for which they are the sponsor.
The Regulation aims to distribute the tasks related to safety assessment proportionally between the Member States, Logically speaking, the Regulation exempts mono-national active substances (i.e., active substances which are used in an investigational medicinal product in clinical trial(s) authorised in only one Member State) from its scope.
The Regulation will become applicable on 31 January 2022, at the same time as the CTR (see, Van Bael & Bellis Life Sciences News and Insights of 9 August 2021).