Clinical trials in public health emergencies

The initiative is focused on enabling multinational clinical trials in the European Union (EU) to promptly tackle public health emergencies (PHE).

Different aspects of the process of clinical trial approval are being tackled, including strengthening collaboration across national competent authorities and medical research ethics committees, and the role of the European Medicines Agency's Emergency Task Force in fostering alignment and discussion across Member States. The possible benefits of a central ethics committee during PHE are also being analysed.

The initiative is also defining a simplified package for submission of applications for clinical trials in PHE and expedited assessments, to facilitate the rapid approval of clinical trials.

ACT EU is also working on enabling regulatory flexibilities in the assessment and conduct of clinical trials, based on the experience gained during the COVID-19 pandemic.

A globe with a warning sign and stop watch to suggest faster clinical trails during public health emergencies

Consultation on draft guidance for the conduct of clinical trials in PHE

ACT EU invites sponsors and other stakeholders involved in running clinical trials in the EU to comment on a draft guidance.

This guidance offers an harmonised approach to conduct clinical trials in a safe and efficient manner during public health emergencies. It includes:

Proposals for regulatory mechanisms to accelerate the authorisation of new clinical trials and changes to ongoing trials during public health emergencies;
Guidance on how to adapt procedures in conduct of clinical trials during public health emergencies.

The document is open for consultation until 30 April 2026.

Draft guidance on the conduct of clinical trials during public health emergencies

You can send your comments to mailema [dot] europa [dot] eu (acteu[at]ema[dot]europa[dot]eu) by completing the template.

Advice on medicines for public health threats

Developers of medicines for health threats that have the potential to cause public health emergencies can apply for scientific advice from EMA, as well as national clinical trial and ethics experts.

This aims to align requirements for clinical trials and marketing authorisation of medicines and vaccines for public health threats at an early stage, speeding up their development and approval.

Guidance for applicants

The advice is offered by EMA's Emergency Task Force. The involvement of ethics experts is made possible through the Public Health Emergencies Ethics Advisory Group established under ACT EU in collaboration with MedEthicsEU.

Joint ETF - ACT EU workshop

In November 2024, EMA's Emergency Task Force (ETF), ACT EU and the ACT EU public health emergencies ethics advisory group held a joint workshop.

The discussions focused on improving preparedness and cooperation during public health emergencies, and on exploring policy options to accelerate clinical trials in the EU.

The workshop report is now available.