Clinical trial procedures and approval processes in Japan

Abstract

Pharmaceutical administration in Japan is governed primarily by the Pharmaceutical Affairs Law (PAL; Law No. 145 issued in 1960) that controls clinical research, manufacturing, marketing, labeling, and safety of drugs, diagnostics, and medical devices (from here on referred to collectively as drugs). The need for a clinical trial notification (CTN) submission to the governing agency before human use of a new drug, for manufacturing/distribution approval application (MAA) before manufacturing/marketing of a new drug product, and for reliability/compliance review on application of a dossier is defined in Articles 80 (2) and 14, respectively, of the PAL. Procedures for implementing the PAL rules are the Enforcement Regulations of PAL (ER-PAL, Ministerial Ordinance No. 1 issued in 1961). Table 1 presents the ER-PAL articles and the laws they describe.