The European Medicines Agency has launched a public consultation for the first release of the Data Quality Framework for the EU medicines regulation.
The draft Data Quality Framework document provides general considerations that can be applied to a wide range of data sources for the purpose of characterizing and assessing data quality for decision-making. It also outlines what data quality actions and metrics can be put in place in different regulatory decision-making scenarios and introduces maturity models for the characterization of data quality for regulatory purposes. The first release of this framework intends to provide an overarching framework to identify, define and further develop data quality assessment procedures and recommendations for current and novel data types. The document has been developed taking into account input from various stakeholder groups that participated in the EMA/HMA/TEHDAS Data Quality Framework workshop on 7 April 2022.
Building a European Data Quality Framework for the regulatory use of data sources with associated quality metrics is one of the key ‘Data Quality and Representativeness’ deliverables set out in the joint HMA-EMA Big Data Steering Group workplan (2022-2025).
Stakeholders and members of the public are invited to submit comments on this framework using by November 18, 2022. The completed form should be sent to dataqualityframework@ema.europa.eu.
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