EMA Guidance on Conducting Clinical Trials during Public Health Emergencies

The Clinical Trials Regulation EU 536/2014 (CTR), and revised or new ICH guidelines (e.g. ICH E6(R3), ICH E8(R1), ICH E19), which came into force following the COVID-19 pandemic, support a risk-based approach in the planning and conduct of clinical trials.

A key lesson from the COVID-19 pandemic is that small, isolated clinical trials or compassionate use programmes in individual Member States may not provide sufficiently robust data for clear medical and public health recommendations. This underscores the need to enrol trial participants in well-designed clinical trials, rather than relying on off-label or compassionate use applications, in order to strengthen the scientific basis for decision-making. In light of these particular considerations, the EMA has published a draft Guidance on the Conduct of Clinical Trials during Public Health Emergencies for comment. 

Clinical Trials During Public Health Emergencies

The draft guidance proposes regulatory mechanisms aiming to accelerate the authorisation of new clinical trials and the approval of modifications to ongoing trials during a Public Health Emergency (PHE). Sponsors are encouraged to seek scientific advice from EMA’s Emergency Task Force (ETF) to ensure trials are well designed, efficient and capable of delivering meaningful data for regulatory assessment.

The draft also provides guidance on transferring trial participants across investigational sites. Due to the specific challenges posed by PHEs, adapted procedures or alternative approaches may be required. During such emergencies, the rights, safety and well-being of trial participants, and the generation of scientifically robust data, remain central to regulatory decisions on clinical trials.

Comments on the draft may be submitted directly to the EMA until 30 April 2026. More information is available at the EMA's News website.