ABSTRACT
The aim of the Phase I clinical trial is to examine the safety and pharmacokinetics of new drugs. The Phase I clinical trial is the first clinical trial in which a drug is administered to human subjects. Japanese laws and regulations concerning drug standards and drug registration rank in the following order: The Japanese Pharmaceutical Affairs Law, The Enforcement Ordinance of the Pharmaceutical Affairs Law, The Enforcement Regulations of the Pharmaceutical Affairs Law and Notifications issued by the Japanese Ministry of Health and Welfare. The purpose of the Japanese Pharmaceutical Affairs Law is to control and regulate matters related to drugs, quasi-drugs, cosmetics and medical devices, to assure their quality, efficacy and safety. The Enforcement Ordinance of the Pharmaceutical Affairs Law ranks below the Japanese Pharmaceutical Affairs Law. In Japan information concerning tests required for new drug registration applications and related guidelines are given in the form of notifications from the Japanese Ministry of Health and Welfare.
