Introduction
Clinical trials are the cornerstone of evidence-based medicine, providing essential data on safety, efficacy, and quality of medicines. During public health emergencies (PHEs), the need for rapid yet safe clinical research becomes even more critical. The Accelerating Clinical Trials in the EU (ACT EU) initiative has published a draft guidance document outlining how clinical trials should be conducted during PHEs. This guidance, now open for stakeholder consultation, targets sponsors and all parties involved in the design, conduct, and oversight of clinical trials within the EU.
Reflecting both the EU legislative framework and guidelines from the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) developed after the COVID‑19 pandemic, the document recommends a harmonised approach to ensure that clinical trials can be initiated, adapted, and continued efficiently and safely in emergency contexts.
Key Recommendations of the Draft Guidance
Accelerated Authorisation and Trial Adaptation
The guidance proposes regulatory mechanisms to accelerate 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 producing robust safety and efficacy data suitable for regulatory assessment.
Participant Safety and Flexibility in Trial Conduct
Special considerations are provided for situations where trial participants may need to be transferred across investigational sites. Adapted procedures or alternative approaches may be required due to challenges posed by public health emergencies. The rights, safety, and well-being of trial participants, along with scientifically sound evidence generation, remain central to all regulatory decisions in these trials.
Public Consultation and Feedback
The draft guidance document is open for public consultation until 30 April 2026. Comments can be submitted using the template provided on the EMA website and sent to: [email protected]. This ensures transparency and stakeholder engagement in shaping regulatory practices for clinical trials during emergencies.
For more information: New guidance on the conduct of clinical trials during public health emergencies in the EU
ACT EU Initiatives Supporting PHE Clinical Trials
Several measures within the ACT EU initiative aim to streamline clinical trials in emergency situations:
- Introduction of a simplified package for clinical trial applications.
- Collaboration between the PHE Ethics Advisory Group and EMA’s ETF to provide scientific advice on medicines for public health threats.
- Regulatory flexibility to adapt trial procedures while maintaining high standards for safety and evidence quality.
These measures ensure that clinical research remains robust, patient-focused, and capable of informing regulatory decisions during urgent public health situations.
About EMA’s Emergency Task Force (ETF)
The ETF is an advisory and support body coordinating regulatory activities in preparation for, and during, public health emergencies, including pandemics. Its responsibilities include:
- Providing scientific and regulatory guidance on the development of medicines and vaccines.
- Supporting sponsors in designing trials capable of delivering meaningful clinical research and pharmacovigilance data.
- Collaborating with regulatory bodies and ethics committees across the EU.
Why Clinical Trial Expertise Matters
Conducting clinical trials efficiently in emergencies requires both operational and regulatory expertise. Organizations often rely on specialized clinical research services to manage protocol design, regulatory submissions, trial oversight, and compliance with Good Clinical Practice (GCP). For structured support in conducting clinical trials while maintaining safety and regulatory compliance, organizations can refer to Baupharma’s Clinical Research Services.
