Regulatory Status of Excipients in Japan

Regulations governing excipients in Japan do not differ remarkably from those in other countries. The general notice in the Japanese Pharmacopoeia states that excipients must be harmless at the administration levels and must not interfere with the therapeutic efficacy or testing of the preparations. Thus, the evaluation of excipients requires an understanding of the preparation as a whole in addition to the inherent quality and safety of the excipients. General procedures involved in application for approval of excipients in Japan are introduced. The precedent of approval is of critical importance. Several points which should be considered describing the entries on quality attributes and safety in an application are explained. Future trends on Good Manufacturing Practice (GMP) and safety guidelines in Japan are also discussed.