From the Position of Japan Pharmaceutical Manufacturers Association (JPMA) / 薬剤疫学

ABSTRACT

Since the reexamination system of new drugs has been in place for about thirty years, it is necessary to reconsider its management. The time from the reexamination application of new drugs until issuance of the results takes several years recently. General drugs are applied during the reexamination application and are approved before reconfirmation of the efficacy and safety of new drugs. Therefore, the reexamination system is not effectively operated. Although the informations for proper use collected from post-marketing investigations and clinical trials, and spontaneous adverse reaction reports of new drugs, etc. during the reexamination period are utilized for its safety measures, the plan for effective use is not systematically managed. We propose an improved plan for a future reexamination system. Further, we propose the introduction of a risk management plan in Japan; the current one of which lags behind EU and US.