EMA Consultation on Data Quality Framework for Adverse Drug Reaction Reports
On 19 October 2026, the European Medicines Agency (EMA) launched a public consultation on a draft chapter of the Data Quality Framework (DQF) for EU medicines regulation. The draft focuses on the collection, management and submission of adverse drug reaction (ADR) reports and aims to support more reliable pharmacovigilance activities and regulatory decision-making across both human and veterinary medicines.
Overview
Authority | EMA |
Date | 19 October 2026 |
Focus | Data quality in adverse drug reaction reporting for human and veterinary medicines |
Type | Public consultation on a draft Data Quality Framework chapter |
Deadline for comments | 14 December 2026 |
What is this about?
The draft applies the existing EU Data Quality Framework to the specific context of ADR reporting. It covers the collection, management and submission of safety data originating from a range of sources, including post-marketing pharmacovigilance activities, clinical studies, medical literature and other reporting channels. It addresses both human and veterinary medicinal products.
The framework considers ADR data quality across five key dimensions: reliability, extensiveness, coherence, timeliness and relevance.
The draft discusses common data quality challenges, including:
Incomplete or missing information
Inconsistent coding practices
Duplicate reports
Variability in causality assessments
Differences in reporting quality across stakeholders and systems
The framework is descriptive rather than prescriptive. It does not introduce new regulatory obligations or replace existing pharmacovigilance legislation, guidance or reporting requirements. Instead, it provides a structured approach to understanding and improving ADR data quality.
Consultation details
The draft identifies seven major areas for improving ADR data quality throughout the data lifecycle:
Education and training Improving awareness of reporting requirements, causality assessment principles and data quality concepts among reporters, data processors and assessors.
Integration of clinical pharmacology Strengthening the role of pharmacological expertise in ADR identification, assessment and safety signal evaluation.
Standardisation Promoting harmonised reporting approaches, consistent terminology and alignment with established standards such as ICH E2B(R3) and relevant veterinary requirements.
Early data validation Applying validation processes and automated checks to identify incomplete, inconsistent or implausible information as early as possible.
Feedback and follow-up mechanisms Improving communication between stakeholders to facilitate corrections, clarifications and collection of follow-up information.
Data integrity and traceability Supporting data immutability, robust version control, audit trails and consistent case identifiers throughout the reporting process.
Duplicate detection and management Strengthening processes for identifying and handling duplicate reports across systems and organisations.
The recommendations address different stages of the ADR data lifecycle, from initial reporting through to regulatory use of safety information.
Useful links
Access the official materials and submit your comments.
Overview of the Data Quality Framework, including related guidance and the current ADR consultation under “Adverse Drug Reactions”
Full source document
Download the comment template provided via EUSurvey
Official online form for submitting comments
Key timeline
Draft dated: 15 October 2026
Start of consultation: 19 October 2026
Deadline for comments: 14 December 2026
Why this matters
The quality of ADR reports directly influences pharmacovigilance activities, including signal detection, benefit-risk assessments and regulatory decision-making across the EU medicines regulatory network.
The consultation builds on EMA’s broader Data Quality Framework and stakeholder discussions on ADR reporting, including a multi-stakeholder workshop held in 2024.
For pharmaceutical companies and other stakeholders, the draft highlights opportunities to strengthen reporting processes, improve data completeness and consistency, and reduce errors throughout the pharmacovigilance data lifecycle. Although the framework does not establish new regulatory obligations, its recommendations provide a basis for evaluating existing practices and identifying potential improvements.
Who should consider responding?
This consultation may be particularly relevant for:
Marketing authorisation holders and qualified persons responsible for pharmacovigilance (QPPVs) involved in human or veterinary medicines
Regulatory affairs and safety data management teams
Clinical trial sponsors and contract research organisations involved in safety reporting
Providers of pharmacovigilance databases and reporting systems
National competent authorities and other stakeholders involved in ADR reporting and assessment
Practical implications
Stakeholders may wish to consider:
Reviewing existing ADR collection, processing and submission procedures against the proposed recommendations
Assessing data validation, coding consistency, duplicate detection and case version management practices
Evaluating training programmes, causality assessment approaches and quality control measures
Identifying operational challenges, particularly where multiple organisations exchange or process safety data
Providing feedback on areas where additional clarification, examples or implementation guidance may be beneficial
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