Future Perspectives for Pharmacovigilance in Japan

Abstract

Drugs are sophisticated intellectual products that have been evolving and specializing. For the efficient use of a drug, while enhancement of pre-marketing review is important, post-marketing monitoring is also essential, since it has been demonstrated that pre-marketing data provide only a limited understanding of the risks involved in the use of drugs. From the perspective of identifying concerns for future pharmacovigilance in Japan, safety measures for recent Adverse Drug Reactions (ADRs) are compared between Japan and the United States of America (U.S.A.) and are classified into the following three main categories: category one for cases in which ADR problems have not become apparent due to “drug lag” in Japan, category two for cases in which Japanese idiosyncrasies have become apparent, and category three for adverse events for which assessment of the causal relationship is difficult. Particularly, category one and category two are peculiar to Japan, and category three is also on the increase in Western countries. Regarding trends in international pharmacovigilance, the results of analysis of trends in safety measures indicated that there is an active movement, mainly in Japan and Western countries, for adoption of the Data Mining method using the databases of ADR reports (spontaneous reports) submitted by medical institutions or companies, and epidemiological studies have been conducted to improve assessment of risk, to facilitate development of a more active safety-monitoring system. In conclusion, as simultaneous, global developments and approvals have been realized in Japan, safety measures should also be implemented simultaneously, efficiently, quickly, and accurately with internationally harmonized approaches in the future.