국내외 경구용 일반방출제제의 허가 후 변경에 관한 규정 비교연구 - 미국, 유럽, 한국을 중심으로 -

A Comparative Study on the Regulation of Post-Approval Changes of domestic and foreign of Immediate Release Oral Dosage Forms: Focused on USA, Europe and Korea

There are many differences in the regulations on the management of the post-authorization change of pharmaceutical products by country. Therefore, it is necessary to analyze the differences in regulations among countries in order to improve of Korean regulations based on global regulations for international harmonization. We compared guidelines related post-approval changes focusing on immediate release solid oral dosage between the United Stats of America, Europe, and Korea for five change categories: change of pharmaceutical ingredient quantity, change of manufacturing site, change of manufacturing scale, and change of manufacturing equipment and process. USA and EU are demanding more data on drug equivalence and stability of pharmaceutical product before and after changes than in Korea. Korean regulations should be improved in order to keep pace with the international harmonization of regulations on change after drug approval. First, it is necessary to thoroughly review drug equivalence such as bioequivalence test and comparative dissolution test of changed drug after drug approval. Lastly, the stability of the changed drug after drug approval should be confirmed after reviewing the stability test result in advance.