EU Issues Regulations for Assigning Safety Event Evaluations to Member States
The European Commission has laid out its regulations for selecting EU member states to evaluate suspected unexpected serious adverse reactions (SUSARs) that occur in clinical trials.
Under the EU’s clinical trial regulations, sponsors are required to submit SUSARs to investigational drugs in trials, as well as yearly safety reports, to the European Medicines Agency. The agency then sends this safety information along to the relevant member state so that they can assist in evaluating it.
Sponsors should send safety information for an active substance that is being studied in just a single member state (what the EU calls “mono-national active substances”) to the “reporting member state” it proposed in its clinical trials application, according to the implementing regulation the commission recently issued. These evaluations should be done in a way “that ensures transparency and enables continuity” in case the active substance moves to a multinational trial.
To that point, the bulk of the implementing regulation concerns selection of a safety assessing member state in specific situations that are handled differently:
- When an active substance enters a multinational trial;
- When the sponsor submits a clinical trial application to more than one member state and at least two member states allow the trial to go forward; or
- When a substantial modification that adds a new active substance to a trial is authorized in at least two member states.
For example, the regulations say that when a sponsor receives two or more authorizations for its clinical trial application, any member state may express interest in taking responsibility for the safety assessment within a week after approval, even if they weren’t the ones to receive the application. Should more than one ask to be the safety assessor, the reporting member state will select one of the applicants within five days after the seven-day deadline to express interest. If none apply, the reporting member state must select a safety assessing member state from the member states concerned within 12 days after a trial is authorized.
Read the full regulations here: https://bit.ly/3nrTkfB.