In spite of ICH activities, there are tremendous gaps between Japanese and western (US and Europe) pharmacovigilance practices. Recent implementation of EU GVP module made this gap evident. Pharmacovigilance systems, procedures, even the concept, are so different, which makes Eastern companies safety information and practices with western companies. From ICSR technical submission to regulations, there are differences which the companies cannot overcome or harmonize. In this session, the differences are compared in respect of pharmacovigilance systems, SOPs, internal audits, risk management, and finally regulatory inspections. Pharmacovigilance regulations continue to evolve rapidly in the developing Asian and Latin American countries. Increasingly these countries require not only that local adverse reaction reports are expedited but that adverse reactions from foreign countries are reported along expedited timelines during clinical development and postmarketing. There is also growing interest in risk management plans (RMP) and an interest in RMPs that companies have submitted to regulatory authorities elsewhere in the world.

This session will review the current status of pharmacovigilance and provide suggestions on how to meet reporting requirements and working with licensing partners and affiliated companies in Japan and the developing world in Asia and Latin America.