A review of candidate companies for procuring pharmacovigilance services in Japan shows that there are no suppliers backed by Japanese capital, with overseas companies’ local operations and partnerships serving as the primary routes into the market.
The list of companies identified as pharmacovigilance suppliers in Japan includes major overseas companies, CROs, and information-services companies, but no suppliers backed by Japanese capital.
The main routes for overseas suppliers to reach buyers in Japan include establishing local subsidiaries or partnering with companies that understand Japanese regulatory requirements, providing Japanese-language procedures and databases, and deploying specialist teams focused on drug safety surveillance.
Key points to confirm when procuring services include adherence to lead times, certification for compliance with the GVP/GCTP ministerial ordinances, 24-hour Japanese-language support, backup arrangements, and a comprehensive assessment of financial soundness and past supply performance.
By use case, drug safety surveillance requires consistent post-marketing safety monitoring, while CROs handle the collection, assessment, and reporting of adverse events during clinical trials, and BPO providers handle business processes such as data entry, document management, and call-center operations.