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EU Consults On Data Quality Framework For Medicines Regulation

 
• By Vibha Sharma

The EU is taking steps to establish a more consistent and standardized approach to the quality of data used in medicines regulation to support benefit-risk decisions.

Standard Quality Control Certification Assurance Guarantee Concept. 3D rendered illustration
EU Wants To Improve The Quality Of Data That Underpins Regulatory Decision-Making • Source: Shutterstock

Regulators in the EU are inviting feedback on a draft framework that seeks to define quality requirements for all types of data used in regulatory decision-making. When finalized, it can help drug companies and other stakeholders in selecting appropriate current and novel data sources for their studies. 

The data quality framework (DQF) was developed by the European Medicines Agency, the EU Heads of Medicines Agencies and the...

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