The European Medicines Agency (EMA), through its Accelerating Clinical Trials in the EU (ACT EU) initiative, published draft guidance on the conduct of clinical trials during public health emergencies (PHEs) for public consultation. The consultation ran from 4 March to 30 April 2026 and has since closed. As of this writing, EMA has not published a finalized version of the guidance, and sponsors and clinical trial units should continue to treat the March 2026 document as a draft signal of regulatory direction rather than settled policy.
What the draft guidance covers
The draft is described by EMA as the first EU-level guidance on public health emergencies to be written against the current legislative baseline — the EU Clinical Trials Regulation (CTR) and the Clinical Trials Information System (CTIS) — and to incorporate the International Council for Harmonisation (ICH) guidance developed in the years following the COVID-19 pandemic, including elements consistent with the direction of ICH E6(R3). It addresses both new trials proposed specifically in response to a declared PHE and modifications to trials already underway when an emergency is declared.
Per EMA’s published materials and contemporaneous regulatory reporting, the draft’s scope includes:
- Accelerated authorisation mechanisms. Proposed regulatory pathways intended to shorten review timelines for new clinical trial applications submitted in direct response to a PHE, building on the coordinated national/EU review model already established under the CTR.
- Faster handling of substantial modifications. Guidance on expedited processing of protocol amendments to ongoing trials — for example changes needed to keep a study running when normal site operations, supply chains, or monitoring visits are disrupted by the emergency itself.
- Scientific advice through the Emergency Task Force (ETF). The draft encourages sponsors to seek early scientific advice from EMA’s ETF, the body already responsible for coordinating EU-level scientific guidance during public health crises.
- Operational continuity provisions. Proposed approaches for handling participant and site-level disruption, including site transfers and continuity-of-care arrangements when a site can no longer safely or practically continue a trial.
The guidance sits alongside — and is meant to be read together with — other ACT EU and ICH output on trial resilience, including the ETF’s separate November 2025 guidance on scientific advice facilitating clinical trial authorisations (SA-CTA), and the broader push toward standardized protocol structure under ICH M11.
Why this matters for sponsors and research administration teams
The COVID-19 pandemic exposed a real gap: neither the EU nor most national frameworks had a pre-agreed, harmonized process for authorising or amending trials at speed when normal timelines and operational assumptions no longer held. Individual member states and EMA improvised case by case. This draft is EMA’s attempt to convert that improvisation into a standing, predictable framework so that the next PHE — whatever it turns out to be — doesn’t require rebuilding regulatory process from scratch.
For clinical trial units, CROs, and sponsors operating in the EU, the practical implications to watch once (and if) a final version is adopted include:
- What documentation an “emergency” designation actually requires to trigger the accelerated pathways described in the draft, and who makes that determination.
- How the accelerated modification process interacts with existing protocol deviation and amendment reporting obligations under the CTR.
- Whether the final guidance sets concrete timelines (rather than best-effort language) for ETF scientific advice and expedited authorisation review.
- How the framework is intended to interact with parallel FDA mechanisms — sponsors running multi-region trials will want to compare the EU approach against EMA and FDA regulatory pathways generally, and specifically against FDA’s own emergency-use and expanded-access tools.
The draft also has an informed consent dimension worth watching: emergency conditions are precisely the circumstances under which existing frameworks already provide narrow exceptions or adapted procedures — see, for context, the U.S. Exception from Informed Consent (EFIC) for Emergency Research pathway and CASRAI’s guide on when informed consent must be obtained, including the emergency exception. Whether and how the EMA draft addresses consent adaptation during a PHE — as distinct from authorisation and amendment speed — is one of the open questions a finalized version should clarify.
Current status
The public consultation window closed 30 April 2026. Stakeholder comments were collected via a template submitted to EMA’s ACT EU mailbox rather than a public comment portal, which means the substance of comments received is not independently visible the way, for example, an FDA docket comment record would be. EMA has not announced a target adoption date for a final version, and no finalized guideline had been identified in EMA’s published guidance library as of this article’s publication. Organizations relying on this guidance for planning purposes should check EMA’s clinical trials guidance page directly before treating any provision described here as final.
Frequently asked questions
Is the EMA public health emergency clinical trial guidance final?
No. As of this writing it remains in draft form. Public consultation closed on 30 April 2026, but EMA had not published a finalized version. Confirm current status directly on EMA’s website before relying on specific provisions.
Who does this guidance apply to?
As drafted, it applies to sponsors, CROs, and other parties conducting or proposing clinical trials in the EU under the Clinical Trials Regulation, both for new trials initiated in response to a declared public health emergency and for modifications to trials already underway when an emergency is declared.
How is this different from ICH E6(R3) or general GCP guidance?
ICH E6(R3) and existing Good Clinical Practice guidance govern trial conduct generally. This draft is narrower and situational: it addresses how authorisation and amendment processes should adapt specifically during a declared public health emergency, building on the ICH framework rather than replacing it.
What should sponsors do while the guidance is still in draft?
Continue operating under current CTR/CTIS requirements and existing emergency-preparedness planning. Treat the draft’s proposed mechanisms — accelerated authorisation, expedited amendment review, ETF scientific advice — as an indication of regulatory direction, not as usable pathways until a final version is adopted and its effective date confirmed.
