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.
EU Consults On Data Quality Framework For Medicines Regulation
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.
