This document presents the Adverse Drug Reaction (ADR) chapter of the Data Quality Framework (DQF) for medicines regulation published by the European Medicines Agency (hereafter referred to as European Medicines Regulatory Network (EMRN) DQF).
It is an extension of the EMRN DQF that specifically addresses collection, management and submission of ADR1 reports in both the human and veterinary domains.
This chapter builds upon existing guidelines and procedures, identifies gaps and provides actionable and focused recommendations for assessing and improving the Data Quality (DQ) of ADR reports pipeline in order to best-support regulatory decision making.
This chapter is intended for all stakeholders involved in ADR collection, management and submission, as identified during the webinar “Multi-stakeholder workshop on Data Quality Framework for Adverse Drug Reaction reporting” [2], and therefore also provides a holistic overview of the overall ADR reporting ecosystem.