Drug Evaluation Committee Translation: Data Quality Framework for EU Medicines Regulation
Data Science Subcommittee Medical Information DBTF
May 2023
On September 30, 2022, the Data Analytics and Methods Taskforce of the EMA prepared the "Data Quality Framework for EU medicines regulation" and issued a request for comments. This document describes high-level principles and procedures for data quality relevant to regulatory decision-making that apply across the regulatory activities of the European Medicines Regulatory Network (EMRN).
In addition to the quality of data from clinical trials, which has been organized in the past, the EMRN encompasses the quality of real-world data from a variety of sources on healthcare and outlines principles and concepts for assessing data quality.
We hope that this report will help you to consider how to consider the reliability of data in promoting the use of real-world data in Japan.
Published May 2023
Committee on Pharmaceutical Evaluation, Japan Pharmaceutical Manufacturers Association
TF for Promotion of Utilization of Medical Information DB / Data Science Subcommittee
Translation: Data Quality Framework for EU Medicines Regulation (963 MB)
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