의약품 첨가제의 공정서 각조의 국제 규격화 : 그 진행과 문제점

International Harmonization of Compendium Monographs of Pharmaceutical Excipients: Its Progress and the Matters at Issue

These days, it is not uncommon that a same kind of drug is circulated globally. However, the qualities of excipients used in the same drug have to be sometimes different depending on the different requirements in the qualities stipulated by each country. For a supplier of pharmaceutical excipients, it is generally necessary to carry out different tests on the same kind of testing criteria depending on the country of destination. Thus, the discrepancies between compendium requirements of pharmaceutical excipients create severe problems in various area of industrial activities. The decision of the United States Pharmacopoeia, European Pharmacopoeia and Japanese Pharmacopoeia Commissions to harmonize the requirements is a unique chance for the industries to overcome these problems. On the other hand, discrepancies of general test methods and requirements in each monograph of pharmaceutical excipient between the compendia valid at present are in most cases extensive. Consequently their harmonization needs a lot of detailed work requiring strong support from the industry. Based on these circumstances, pharmaceutical excipients councils have been established first in U.S.A. and successively in Europe and in Japan to contribute to the harmorization process. We should like to review here the progress since the Orlando Conference in 1991 and comment about the matters at issue with regard to the international harmonization of pharmaceutical excipients.