Ethnicity-Specific Drug Safety Data in European Medicines Agency Registration Dossiers, European Public Assessment Reports, and European and Singapore Drug Labels: Lost in Translation?

摘要

Background Information on drug safety in different ethnic populations reported in public documents such as the European Public Assessment Reports (EPARs), European Summary of Product Characteristics (SmPCs) or Singapore Package Inserts (SGPIs) generally appeal's limited. Objective This study aimed to clarify the extent of drug safety data in ethnic populations that is available in drug registration dossiers used for registration in the European Union (EU) and Singapore, and how much of this information is then included in the EPARs and SmPCs or SGPIs. Methods For this purpose, drug registration dossiers and these public documents for a selection of 25 drugs authorized both in the EU and Singapore were compared (note, the number of available full registration dossiers was only 24 due to a technical issue). Results Detailed safety data in ethnic groups were present in 23/24 (96%) of the drug registration dossiers, but was only present in 12/25 (48%) of the EPARs, 8/25 (32%) of the SmPCs, and 9/25 (36%) of the SGPIs. Furthermore, in many cases where ethnicity-specific safety information was provided in the SmPC or SGPIs, details on the ethnic subpopulations was not provided.