The European Medicines Agency (EMA) has released draft guidance for sponsors conducting clinical trials during public health emergencies (PHEs).
The guidance, published through the Accelerating Clinical Trials in the European Union (ACT EU) initiative, outlines how both new and existing studies should be conducted during PHEs.
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The US Food and Drug Administration (FDA) released guidance on the conduct of clinical trials in major disruptions due to disasters and PHEs in September 2023.
This is the first guidance from the EU on PHEs to reflect the current legislative framework, as well as the guidelines from the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) developed following the Covid‑19 pandemic. It recommends a harmonised approach to ensure that clinical trials can be initiated, adapted and continued efficiently and safely when public health emergencies arise.
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.”
The guidance proposes regulatory mechanisms aiming to accelerate the authorisation of new clinical trials and the approval of modifications to ongoing trials during a 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.
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By GlobalDataFor new studies, the EMA states that “timely generation of robust and reliable evidence is essential” and that “trial design, procedures and oversight” should be “fit for purpose and take into account the nature and scale of the emergency”.
For studies which were already ongoing before the PHE, sponsors are asked to consider whether protocols can be amended, site visits reduced or decentralised with technology, as well as other considerations to ensure patients are protected during trials.
The guidance also allows for situations in which trial patients can be transferred across investigational sites. Adapted procedures or alternative approaches may be required due to the specific challenges posed by PHEs.
The draft guidance document is open for public consultation until 30 April 2026.
