Background: Japanese pharmaceutical authorities have conducted regulatory renovations of pharmacovigilance planning (PVP) since implementing new procedures for developing post-marketing study plans in 2018 in order to promote more focused and scientific approaches. This study aimed to descriptively assess the effects of those regulatory renovations on PVP for new drugs in Japan.
Methods: We identified PVP information (drug characteristics, efficacy and safety issues, and additional activities) from the first version of risk management plans for new drugs approved between 2016 and 2019. The following indicators were analyzed: (1) proportion of the number of drugs with at least one efficacy issue among all the drugs, (2) proportion of the number of safety issues with additional activity among all the safety issues, and (3) proportion of database studies among all additional activities.
Results: In total, 168 drugs, 1212 safety issues, and 301 additional activities were identified. The proportion of drugs with at least one efficacy issue decreased from 91.4% in 2016 to 27.3% in 2019, and the proportion of safety issues with additional activity also decreased from 93.9% in 2016 to 53.7% in 2019. In contrast, the proportion of database studies increased from 0 to 19.2%. The percentages of additional activities targeting important identified and potential risks also gradually decreased during the 4-year period.
Conclusion: Notable changes in the three indicators during 2016-2019 were observed, which suggests that regulatory renovation has affected PVP in Japan.
Keywords: Drug efficacy; Drug safety; Pharmacovigilance; Policy impact evaluation; Post-marketing study; Risk Management Plan.
© 2022. The Author(s), under exclusive licence to The Drug Information Association, Inc.