ABSTRACT

Kanebo Cosmetics Inc., Products Science Research Laboratory, Kanagawa, Japan

INTRODUCTION

In Japan, drugs and cosmetics come under the jurisdiction of the Ministry of Health, Labour and Welfare, and are regulated by the Pharmaceutical Affairs Law (PAL). The PAL was promulgated and came into operation after the Second World War in 1948 under the guidance of the General Headquarters (GHQ). At the time, the system of government deployed by the GHQ was patterned after the U.S. Administration, as was the enactment of the PAL. Together with the restoration of Japan’s autonomy, and reflecting the tone of the times in which intense interest was stirred in quality, efficacy, and safety, the New PAL was promulgated in 1960. Thereafter, the Law has been amended several times.