초록

미국 FDA와 일본 후생성의 후발 약품 허가 관리 제도를 검토하여 우리나라와 선진국와 제도상 차이점에 대한 타당성을 검토하였으며 또한 이들 선진국과 우리나라의 GMP 규정을 검토하여 차이점을 파악하였다. 궁극적으로 검토된 내용을 기반으로 하여 우리나라의 실정에 맞는 제네릭 의약품 허가 제도의 도출하고자 하였다.

Abstract ▼

With the advent of new pharmacy law enforcing the use of prescription for virtually all drugs, a considerable confusion has erupted in Korea for the last two years. The primary reason for the confusion is the lack of bioequivalent formulations for a give drug. To address the social problem, KFDA has

With the advent of new pharmacy law enforcing the use of prescription for virtually all drugs, a considerable confusion has erupted in Korea for the last two years. The primary reason for the confusion is the lack of bioequivalent formulations for a give drug. To address the social problem, KFDA has initiated a bioequivalence testing for a list of important drugs. However, we wished to study whether the current guideline for the bioequivalence testing is compatible with guidelines enforced in developed countries. We were particularly interested in the differences in the guidelines and scientific validity of the differences. Our ultimate aim is to propose Korean guideline of bioequivalence testing that is compatible with developed countries and scientifically valid. According to guideline published in public, Korean, US, and Japanese guidelines for bioequivalence testing appear quite similar generally, while there exists subtle differences. The most notable difference between the countries was the SUPAC (scale-up and post approval changes) guidelines in the US. The SUPAC guideline specifies the extent of changes in the additives in the formulation for the human study. While the scientific validity of the SUPAC guideline is still not clear, the prevention of potential bioavailability problems appears prudent. Therefore, a Korean version of SUPAC guideline appear necessary for the further enhancement of qualities of drug products. The other notable difference in the three bioequivalence guidelines was that, in Japan, the necessity of human study is determined according to a systematic dissolution testing of drug products. It is generally believe that dissolution testing may be readily carried out while the human study takes a considerable amount of time and man-power. It appear, therefore, the Japanese version of the bioequivalence testing is scientifically valid and productive approach. In summary, we have identified a key differences between three guidelines. We believe that there exist certain advantages of guidelines of developed countries (e.g., SUPAC guideline in US; a systematic dissolution testing in Japan). Therefore, we. believe the these advantages have to be taken into consideration for the future revision of bioequivalence testing guideline in Korea.

목차 Contents

• 표지 ... 1
• 최종보고서 ... 2
• 제출문 ... 4
• 요약문 ... 5
• 영문요약문 ... 6
• 제1장 서론 ... 7
• 제2장 국내.외 기술개발 현황 ... 8
• 제3장 연구개발 수행 내용 및 결과 ... 11
• 제1세부과제 ... 11
• 제2위탁과제 ... 30
• 제4장 연구개발목표 달성도 및 대외기여도 ... 127
• 연구개발목표의 달성도 ... 127
• 연구개발 목표의 대외기여도 ... 127
• 제5장 연구개발결과의 활용성과 및 계획 ... 128
• 가. 계량적 성과 ... 128
• 나. 성과내용기술 ... 128
• 다. 활용계획 ... 128
• 제6장 기타 중요변경사항 ... 128
• 제7장 참고문헌 ... 128
• 연구(세부)과제 요약 ... 130