The European Medicines Agency (EMA) has opened two public consultations on the methodology of confirmatory platform trials and the quality of adverse drug reaction (ADR) reporting data. The consultation deadlines are 31 January 2027 and 14 December 2026, respectively.

Draft reflection paper addresses confirmatory platform trials

The draft reflection paper on methodological aspects in confirmatory platform trials was published for consultation on 19 October 2026. It aims to complement existing guidance on multiplicity and adaptive trial designs, rather than replace or revise current guidance.

Platform trials allow multiple treatments to be evaluated within a single clinical trial, with treatment arms added or discontinued as evidence accumulates. The EMA paper focuses on their use as confirmatory trials intended to provide pivotal evidence for regulatory decision-making. It examines key methodological issues, including pre-specification, randomisation, control groups, blinding, type I error control, statistical operating characteristics and estimands.

The consultation is open until 31 January 2027. The document is available on the EMA’s open consultations page under reference number EMA/217509/2026.

Data quality framework for adverse drug reaction reports

EMA has also opened a consultation on a draft chapter of the Data Quality Framework (DQF) for EU medicines regulation. The document covers the collection, management and submission of ADR reports in both human and veterinary medicine.

The draft identifies data-quality challenges across five dimensions: reliability, extensiveness, coherence, timeliness and relevance. It also proposes measures to improve reporting processes, including staff education, earlier data validation, feedback mechanisms for correcting records and routine detection of duplicate reports. The recommendations address stakeholders involved in submitting ADR data to EudraVigilance and EudraVigilance Veterinary.

The chapter is descriptive rather than prescriptive: it does not replace existing legislation or guidance and does not introduce additional requirements for stakeholders.

The consultation began on 19 October 2026 and closes on 14 December 2026. The draft is listed under reference number EMA/87692/2025. Stakeholders can submit comments through the dedicated EUSurvey forms linked from the relevant consultation entries on the EMA website.