Safety Assessment of Clinical Trials

Recommendation

5/6 June 2024

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To ensure effective and efficient safety assessment of clinical trials, the EU Commission published rules and procedures for the cooperation of the Member States. A risk-based approach should define the frequency of screening of safety information, the extent of its assessment and the timelines of assessment and reporting. The new Regulation will become applicable at the same time as the Clinical Trials Regulation (EU) No 536/2014 (CTR) - on 31 January 2022.

Scope

The new Regulation applies to all active substances that are used in investigational medicinal products (IMPs) in clinical trials authorized in at least two EU Member States, regardless of whether the clinical trial in question was authorized under the CTR or initially under Directive 2001/20/EC and subsequently under the CTR. It does not apply to mono-national active substances, to active substances in IMPs used as a reference product, or to active substances used in auxiliary medicinal products (AxMPs).

Coordinated Safety Assessment

A safety assessing Member State (SAMS) shall be selected for each active substance that is used in clinical trials authorized in the EU in accordance with the CTR, in each of the following situations:

• The sponsor submits to more than one Member State an application dossier for the authorization of a clinical trial with a new active substance for safety cooperation and at least two Member States authorize that clinical trial;
• A substantial modification adding a new active substance for safety cooperation to a clinical trial is authorized in at least two Member States;
• A mono-national active substance becomes a multi-national active substance.

Screening and assessment of suspected unexpected serious adverse reactions (SUSARs)

• The screening of the EudraVigilance database shall take place at least once every 15 calendar days.
• For IMPs with a marketing authorization in the Union, the SAMS may decide to decrease the screening frequency to at least once every 30 calendar days.
• When the state of knowledge about the safety profile of the active substance (or the degree of deviation in the use of the active substance from normal clinical practice) so requires, the SAMS shall apply a higher screening frequency.

The European Medicines Agency (EMA) shall provide information systems to support the screening procedures.

For more information please see Commission Implementing Regulation (EU) 2022/20 on setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials.