Regulatory Status of Excipients in Japan
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Drug Infomarion Journal, Vol. 33, pp. 27-32. 1999 Printed in the USA. All rights reserved.
REGULATORY STATUS OF EXCIPIENTS IN JAPAN MITSURUUCHIYAMA, PHD President, Society of Japanese Pharmacopoeia, Tokyo, 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 efFcacy 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 trendr on Good Manufacturing Practice (GMP) and safety guidelines in Japan are also discussed. Key Words: Excipient regulation in Japan; Regulation of excipients; Quality of excipients; Safety of excipients; GMP of excipients
INTRODUCTION
with the therapeutic efficacy nor the testing of the preparations.” It can, therefore, be seen that the regulation of an excipient requires not only a careful evaluation of the inherent quality and safety of the excipient, but also a complete understanding of the pharmaceutical product in which it is contained. In every case, as a basic premise for evaluation of excipients, the requirement for an evaluation of the quality attributes and safety of the excipient depends upon whether or not the excipient has been previously approved for use for the particular route of administration and for the particular dose level. The regulation of excipients consists first of a determination of whether or not the excipient fulfills the objective of its inclusion to improve or enhance quality and function of the pharmaceutical product in which it is included. The excipient must not compromise the effectiveness or safety of the product,
THE REGULATION OF pharmaceutical excipients in Japan does not differ markedly from that in other countries. Regulation is carried out to determine whether the excipient in question is appropriate for use. The General Rule for Preparations in the Japanese Pharmacopoeia states that: “suitable excipients may be added to pharmaceutical preparations to assure the specified properties and quality during storage or enhance the usefulness. These excipients, however, must not only be harmless at regular dosage levels, they also may not interfere Presented at the DlA 34th Annual Meeting “Thinking Globally: Product Development, Registration, and Marketing in the New Millenium,” June 7-1 l , 1998, Boston, Massachusetts. Reprint address: Mitsuru Uchiyama. Nagamine 33-5-70 1, Inagi, Tokyo 206-082 1, Japan.
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Mitsuru Uchiyama
or otherwise hinder testing of
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