초록 ▼

필요성 및 목표
○ 「대한민국약전」일반정보는 품질관리자에게 약전 이용의 편의성을 제공하기 위한 것으로, 제약업체의 품질관리에 유용한 새롭고 다양한 정보를 제공하고 있음
○ 「대한민국약전」제 11개정 수재 일반정보는 15건으로 미국약전(135건)과 유럽약전(37건)에 비해 제공되는 정보가 현저히 적어 정보 추가 및 지속적 관리가 필요함
○ 국제수준의 대한민국약전 일반정보 제·개정(안) 마련

방 법 및 결 과
○ 국내·외 약전(미국약전, 유럽약전, 일본약전) 일반정보 비교검토
- 수재 목록, 분야

필요성 및 목표
○ 「대한민국약전」일반정보는 품질관리자에게 약전 이용의 편의성을 제공하기 위한 것으로, 제약업체의 품질관리에 유용한 새롭고 다양한 정보를 제공하고 있음
○ 「대한민국약전」제 11개정 수재 일반정보는 15건으로 미국약전(135건)과 유럽약전(37건)에 비해 제공되는 정보가 현저히 적어 정보 추가 및 지속적 관리가 필요함
○ 국제수준의 대한민국약전 일반정보 제·개정(안) 마련

방 법 및 결 과
○ 국내·외 약전(미국약전, 유럽약전, 일본약전) 일반정보 비교검토
- 수재 목록, 분야 및 기준 등
○ 개정 및 신규 수재 대상 일반정보 목록 마련
- 현 과학수준에 적합하고 타당한 시험법으로 개정
○ 산·학·관 전문가 자문 및 KP포럼 등을 통한 의견 수렴
○ 국제적 수준의 대한민국약전 일반정보 개정(안) 확대 제시 (30 종)

기대성과
○ 의약품 품질관리 시 널리 사용되는 일반정보의 추가 제공 및 지속적
정보 관리를 통하여 대한민국 약전의 국제조화를 달성

Abstract ▼

The Ministry of Food and Drug Safety (MFDS) maintains and manages Korean Pharmacopoeia (KP), the official compendium of Korea, on an ongoing basis for the purpose of improving and ensuring quality management of drugs, and strives to present up-to-date standards through the establishment and revision

The Ministry of Food and Drug Safety (MFDS) maintains and manages Korean Pharmacopoeia (KP), the official compendium of Korea, on an ongoing basis for the purpose of improving and ensuring quality management of drugs, and strives to present up-to-date standards through the establishment and revision of the provisions. It is essential that pharmacopoeias be continually revised according to current conditions, especially due to ceaseless advances in scientific technology and devices and development of new analytical methods. Accordingly, even advanced nations such as the U.S., EU member states, and Japan are continually updating their standards relevant to domestic drugs.
Over the years, KP revisions have helped gradually reduce the gap between Korea and the major advanced nations in terms of test methods and criteria; however, the general information included in KP has not been managed as thoroughly, and the fact is that the available information falls short of meeting current scientific standards in both quantity and quality.
The general information in KP is provided to facilitate its use by drug quality management officers. While it provides new and diverse information that is useful in quality management by pharmaceutical companies, there are only 15 general information items listed in the Korean Pharmacopoeia 11th Edition (KP 11), which is considerably fewer than in the U.S. Pharmacopoeia (135 items), European Pharmacopoeia (37 items) and Japanese Pharmacopoeia(41 items). This suggests the need to add and continually manage this information.
In this research project, the general information included in the Korean compendium was analysed against that of the U.S., European and Japanese Pharmacopoeias to identify common characteristics and differences. In addition, 30 general information items among the foreign compendia that are widely used in drug quality management were selected. In order to achieve international harmonization and prepare a draft of general information appropriate for domestic circumstances, an industrial-academic-governmental expert consultative group was formed to exchange advice and information, and information was also collected from foreign sources to ensure reliability. It is deemed that the 30 general information items selected for the KP revision will facilitate the use of KP among drug quality management officers and provide useful information on quality management for pharmaceutical companies.Furthermore, there are plans to attain the international harmonization of KP by continually managing the general information sources.