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

There are many differences in the regulations on the management of the post-authorization change ofpharmaceutical products by country. Therefore, it is necessary to analyze the differences in regulations among countries inorder to improve of Korean regulations based on global regulations for international harmonization. We comparedguidelines related post-approval changes focusing on immediate release solid oral dosage between the United Stats ofAmerica, Europe, and Korea for five change categories: change of pharmaceutical ingredient quantity, change ofmanufacturing site, change of manufacturing scale, and change of manufacturing equipment and process. USA and EU aredemanding 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 changeafter drug approval. First, it is necessary to thoroughly review drug equivalence such as bioequivalence test andcomparative dissolution test of changed drug after drug approval. Lastly, the stability of the changed drug after drugapproval should be confirmed after reviewing the stability test result in advance. KCI Citation Count: 0