Japan

Pharmacovigilance in Japan is regulated by the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) under Japan's own GVP and post-marketing safety framework. Japanese GVP requires the relevant marketing-authorisation holder to appoint national safety-management roles, including the Safety Management Supervisor (Anzen Kanri Sekininsha), rather than an EU QPPV; Japan likewise does not use the EU PSMF as its national system-file model. Company adverse-reaction reporting is category-dependent, with core 15-day and 30-day reporting categories. Periodic safety reporting follows Japan-specific approval and PMDA/MHLW requirements, and Japan maintains a formal RMP framework. Japanese GVP and PMDA/MHLW requirements govern locally. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.