EMA Draft Guidance on Clinical Trials During Public Health Emergencies

EMA News

Published March 5th, 2026

Detected March 5th, 2026

Summary

The European Medicines Agency (EMA) has published draft guidance for conducting clinical trials during public health emergencies. This guidance, open for consultation until April 30, 2026, aims to streamline the authorization of new trials and modifications to ongoing trials.

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What changed

The European Medicines Agency (EMA) has released a draft guidance document for stakeholder consultation on the conduct of clinical trials during public health emergencies (PHEs) within the EU. This guidance, developed under the ACT EU initiative, provides recommendations for sponsors and trial parties, reflecting the current EU legislative framework and ICH guidelines post-COVID-19. It proposes mechanisms to accelerate the authorization of new trials and the approval of modifications to ongoing trials, encouraging sponsors to seek scientific advice from EMA's Emergency Task Force (ETF) and addressing potential challenges like participant site transfers.

This draft guidance is open for public consultation until April 30, 2026, with comments to be submitted via a provided template to acteu@ema.europa.eu. The primary goal is to ensure that clinical trials can be initiated, adapted, and continued efficiently and safely during PHEs, while maintaining the rights, safety, and well-being of participants and ensuring the generation of scientifically robust data. Regulated entities involved in clinical trials should review the draft guidance and submit comments by the deadline to influence the final document.

What to do next

Review the draft guidance on conducting clinical trials during public health emergencies.
Submit comments using the provided template by April 30, 2026.
Consider seeking scientific advice from EMA's Emergency Task Force for trial design during potential PHEs.

Source document (simplified)

New guidance on the conduct of clinical trials during public health emergencies in the EU

5 March 2026

Recommendations to streamline authorisation of new clinical trials and changes to ongoing trials to generate clinical evidence News Human Clinical trials

The Accelerating Clinical Trials in the EU (ACT EU) initiative has published a draft guidance document outlining how clinical trials should be conducted during public health emergencies (PHEs). The guidance, now open for stakeholder consultation, is intended for sponsors and all parties involved in the design and conduct of clinical trials in the EU.

This is the first guidance on PHEs to reflect the EU’s 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 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.

The draft also provides guidance for situations in which trial participants can be transferred across investigational sites. Adapted procedures or alternative approaches may be required due to the specific challenges posed by public health emergencies. The rights, safety and well-being of trial participants and the generation of scientifically robust evidence remain central to regulatory decisions on clinical trials during such emergencies.

This draft guidance document is open for public consultation until 30 April 2026. Comments should be included in the template available below and sent to: acteu@ema.europa.eu.

ACT EU work on clinical trials in public health emergencies

Several aspects concerning the authorisation of clinical trials during emergencies are being addressed under ACT EU, including a simplified package for clinical trial applications and the collaboration of a recently established PHE Ethics Advisory Group with the ETF in providing scientific advice for medicines for public health threats.

About EMA’s Emergency Task Force (ETF)

The ETF is an advisory and support body responsible for coordinating regulatory activities in preparation for and during public health emergencies, including pandemics. It provides scientific and regulatory guidance to support the development of medicines and vaccines for preparedness and/or use during outbreaks and emergencies.