Analysis of safety specifications in risk management plan at the time of drug approval and addition of clinically significant adverse reactions in the package insert post-approval in Japan.

ABSTRACT: Recently, post-marketing safety measures have been considered critical in Japan due to the globalization of drug development and the introduction of new drug approval systems. Pharmacists are expected to play an active role in ensuring the safety of drugs post-approval. Utilizing risk management plans (RMPs) to ensure safety throughout the development and post-marketing phases is becoming even more critical. In this study, we examine the relationship between the safety specifications (SSs) in RMPs at the time of drug approval and the adverse reactions (ARs) added to the clinically significant adverse reactions (CSARs) section of the package inserts (PIs) post-approval to determine whether SSs constitute useful drug information for pharmacists. The analysis included new active ingredient-co

SUBMITTER: Saito R 

PROVIDER: S-EPMC10293701 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature