Publication date: 19-Oct-2026
Intelligence Overview
The European Medicines Agency (EMA) has published a draft chapter of the Data Quality Framework (DQF) for EU medicines regulation, focusing on the collection, management and submission of Adverse Drug Reaction (ADR) reports.
The document aims to identify data quality challenges and provide recommendations to improve the reliability and usefulness of safety data for regulatory decision-making across both human and veterinary medicines.
Key Highlights:
The draft framework identifies five key dimensions of data quality in ADR reporting:
- Relevance: Ensuring the data are appropriate for their intended regulatory use.
- Reliability: Ensuring reported data accurately represent the information they are intended to capture.
- Extensiveness: Assessing whether the data collected are sufficiently complete.
- Coherence: Ensuring data can be analysed consistently as a whole.
- Timeliness: Ensuring safety data are available when needed.
Regulatory Impact
The draft is relevant to Marketing Authorisation Holders (MAHs), clinical trial sponsors, national competent authorities and other stakeholders involved in pharmacovigilance. It addresses ADR reporting across clinical trials and post-marketing activities, covering both human and veterinary medicines.
Improved data quality can support more consistent safety assessments, better signal detection and more informed regulatory decisions.
Important: This document is a draft and does not replace existing legislation or guidance, nor does it introduce additional stakeholder requirements.
Public Consultation Timeline
- Consultation opened: 19 October 2026
- Deadline for comments: 14 December 2026
Stakeholders are encouraged to review the draft and submit feedback through the consultation mechanism provided by EMA.
Source: https://www.ema.europa.eu/fr/media/75672 https://www.ema.europa.eu/en/news-events/whats-new