Date of Publication: 04-Mar-2026
INTELLIGENCE OVERVIEW
Agency: EMA
The European Medicines Agency (EMA) has released a draft guidance on the conduct of clinical trials during public health emergencies, published on 27 February 2026, with public consultation open until 30 April 2026. The guidance aims to ensure that clinical trials can continue efficiently during emergencies such as pandemics while maintaining patient safety, ethical standards, and reliable data generation.
The document outlines regulatory flexibilities and risk-proportionate approaches for initiating new trials and managing ongoing studies during crises. It encourages prioritisation of trials addressing the public health emergency, while allowing adaptations such as remote informed consent, telemedicine visits, remote monitoring, and direct shipment of investigational products to participants when site access is restricted.
The draft guidance reflects lessons learned from the COVID-19 pandemic and aligns with the principles of the Regulation (EU) No 536/2014 and international standards such as ICH E6(R3) Guideline on Good Clinical Practice. Stakeholders are encouraged to review the draft and provide comments during the consultation period before the final guidance is adopted.
KEYWORDS: Clinical Trials, Decentralised Trials, International Standards
REFERENCE: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guidance-conduct-clinical-trials-during-public-health-emergencies_en.pdf https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines