12th Annual Meeting DIA Japan 2015

Performing multinational clinical studies can, in principle, offer the opportunity to propose a consistent list of adverse reactions and frequencies for inclusion in the Japan PI, US PI and EU SmPC. There are, however, differences in the criteria used in deciding which events qualify to be included in labeling as adverse reactions – for example, to what extent to follow the investigators’ causality assessment. This session reviews factors that may lead to regional inconsistencies in the list of labeled ADRs. There are also differences between the regions in how frequency information for adverse reactions is expected to be generated. For example, in the J-PI, ADR frequencies should be based on the subset of reported adverse events for which investigators could not exclude a causal association with drug exposure. In the US PI and SmPC, frequency information is usually based on all reported events, irrespective of investigator’s causality assessment. This session discusses these issues and other factors that le ad to inconsistent selection of adverse reactions and frequency information, their impact on the preparation of regional labeling and the CCDS, and explores possible ways forward. It also discusses the internal business rules and procedures for managing regional deviations from CCDS in order to meet European GVP expectations and limit the risk of product litigation in the U.S.A.