Accelerating Clinical Trials in the EU (ACT EU) has issued new draft guidance that outlines clinical trial conduct during public health emergencies (PHEs). Public consultation is open until 30 April 2026.
The draft guidance, ‘Guidance on the Conduct of Clinical Trials during Public Health Emergencies’, has been developed to reflect the EU’s current legislative framework, as well as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines that were developed after the COVID-19 pandemic. The guidance is intended for drug developers and all parties involved in the design and conduct of clinical trials in the EU.
The aim of the guidance is to direct drug developers on how standard clinical trial conduct can be adapted to allow trials to be initiated, modified and continued while ensuring that the core ICH principles of ensuring participant safety and veracity of data are maintained during a PHE. Regulatory mechanisms are proposed to help speed up the initiation of new trials and the approval of changes to ongoing trials.
A detailed section on adaptations to key aspects of clinical trial conduct is provided, which includes subsections of informed consent, safety monitoring and reporting, investigational product management and trial management. Drug developers should request advice from the European Medicines Agency’s Emergency Task Force to ensure that their trials are well-designed and yield reliable, robust and meaningful results from a regulatory point of view.
The guidance reads: ‘A key lesson learnt from the COVID-19 pandemic is that small, isolated clinical trials or compassionate use programmes in individual Member States may not generate sufficiently robust evidence for clear medical and public health recommendations. This underlines the need to prioritise the inclusion of trial participants in well-designed clinical trials over off-label or compassionate use in order to strengthen the scientific basis for decision making.’
Comments should be provided using this template. The completed comments form should be sent to acteu@ema.europa.eu by 30 April 2026.
