わが国における医薬品医療機器の開発ならびに導入の現況

Development and Evaluation of New Drugs and Medical Devices in Japan―Standpoint of Regulatory Agency

Ⅰ．わが国における医薬品医療機器承認審査の歩み

　わが国における医薬品・医療機器の承認審査は，長らく厚生省（現厚生労働省）において行われてきた。しかし，本格的な承認審査体制を構築し審査内容の高度化などを図るため，1997年国立医薬品食品衛生研究所に医薬品医療機器審査センターが設置され，医学，薬学，生物統計学などの専門の審査官によるチーム審査が行われることとなった。

　その後，1997年から3カ年計画で審査センターにおける審査官の増員が図られたものの，国の組織としてさらに体制整備を行うことには限界もあった。このため，審査センターと医薬品の副作用による健康被害の救済や医薬品の研究開発振興等の業務を行っていた（認）医薬品副作用被害救済・研究振興調査機構，医療機器の同一性調査を行っていた（財）医療機器センターの機能を統合し，2004年4月独立行政法人医薬品医療機器総合機構（Pharmaceuticals and Medical Devices Agency，PMDA）が発足した（Fig.1）。

Abstract

　Since 2004, the process of evaluation and approval review of new drugs and new medical devices in Japan has been undertaken by the Pharmaceutical and Medical Devices Agency (PMDA), which was established in the same year.

　PMDA conducts timely evaluation in order to ensure that public and healthcare professionals gain the maximun benefit of advanced, safe drugs and medical devices.

　The Japanese government has decided to reduce the "drug lag" by 2.5 years until fiscal year (FY) 2011.　To achieve this goal, PMDA has undertaken some measures such as including increasing the number of reviewers reducing the period of development by significantly improving consultation services, developing guidance toward the introduction of prior assessment consultation system.　Moreover, to improve of post-marketing safety measures, PMDA established a support system incorporating the data mining method.

　It is the PMDA's responsibility to put in its best efforts towards evaluateing various conflicting issues and appropriately balance them by assessing risks and benefits on the basis of the present scientific knowledge,in a manner that is most beneficial for public interest.　Regulatory science thus provides a scientific basis for regulatory decisions.　We strive to promote the regulatory science by establishing communication with external scientists and providing enhanced training to improve the staff's capability to apply regulatory science.