I. 임상시험이란 무엇인가?: 4. 임상시험 관련규정 및 윤리
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I. 임상시험이란 무엇인가?
4. 임상시험 관련규정 및 윤리
*약물 및 임상시험 관련 규정/법규의 역사
❖1848년에 제정된 수입의약품법(Import Drug Act)에 의회를 통과한 것이 출발점
-미 농무부(United States Department of Agriculture, USDA)산하 화학과에서 식품과 의약품의 불순물 혼입(adulteration)을 조사 시작
- 1883년 농무성 산하의 화학국으로 확대개편
•미국FDA의 약물규정 법령 변천사
1.무해식품 및 의약 관련 법령(pure Food and Drug Act, 1906)
- 가공식품으로부터 소비자보호,식육업체,식품재벌 비리 근절을 위한 육류 검사법(Meat Ispect Act)및 식품의약법(Pure Food and Drug Act)통과
- 최초의 약품관련 법규,최초의 식품과 의약품의 준비 및 생산을 통제하는 연방 정부 기관 탄생
2.셀리 개정(Sherley Amendment, 1912)
•소비자를 속이려는 의도로 라벨에 치료효과에 대한 잘못된 주장을 표기하는 것을 금지하는 법령 개정
3.식품의약품청FDA창성(FDA Open,1930)
•1930년 농무부 산하의 화학국 내 식품의약품관리청이 식품의약품청(FDA)으로 독립
•1955년 미국 연방 보건교육복지부 산하의 공중보건서비스(Public Health Service)소속 연방기관
•1979년 보건후생부(Department of Health and human Services)의 하부기관으로 개편
-식품과 의약품에 대한 모든 것을 관리하는 규제기관으로 발전
-현재:식품의 규격과,관련규제의 제정,영양소 기준,약품,백신,의학 및 혈액 관련 물품,의료 및 방사능 측정 기구, 화장품 등 다양한 분야의 안전규칙 제정 기관
4.미 식품-의약품-화장품 규제법령(food, Drug, Cosmetic Act,1938)
•1937년 설파닐아미드 엘릭서 사건으로 식품-의약품-화장품 규제 법령 통과
-모든 의약품 제조업자는 제품을 판매하기 전에 반드시 해당 의약품의 의약품을 표시하고 그 안전성을 입증
-FDA눈 식품,의약품 뿐만 아니라 의료기기,화장품까지 규제 확대
-1912년 셀리 개정은 삭제 됨
5.더햄-험프리 개정(The Durham-Humphrey Amendment,1951)
•의약품의 분류를 법의로 규정하고 처방약과 비처방약의 분류에 대한 기준
-분류군의 확정은FDA가 담당
-의약분업으로 의사의 처방관과 약사의 조제권 엄격히 구분 및 의무화
•1958년 델라니 조항(Deleney Clause)[식품 속 발암성 물질의 사용 일절 금지]추가
6.케파우버-해리스 개정(The Kefauver-Harris Amendment, 1962)
•1962년 탈리도마이드 사건 발생 이후 식품-의약품-화장품 법에 대한 강화된 수정안
-해당의약품이 반드시 효과가 잇다는 유효성 입증과 안전성에 관한 증거로 독성 실험 자료를 제출해야 한다는 규정: 현재IND신정 규정의 기초
-의약품 허가를 위해 실질적인FDA의 사전승인을 유구
-약물의 이상반응에 대한 의무적인 보고와 고지를 통해 위험성에 대한 발표를 요구
I. 임상시험이란 무엇인가?
4. 임상시험 관련규정 및 윤리
*약물 및 임상시험 관련 규정/법규의 역사
❖1848년에 제정된 수입의약품법(Import Drug Act)에 의회를 통과한 것이 출발점
-미 농무부(United States Department of Agriculture, USDA)산하 화학과에서 식품과 의약품의 불순물 혼입(adulteration)을 조사 시작
- 1883년 농무성 산하의 화학국으로 확대개편
•미국FDA의 약물규정 법령 변천사
1.무해식품 및 의약 관련 법령(pure Food and Drug Act, 1906)
- 가공식품으로부터 소비자보호,식육업체,식품재벌 비리 근절을 위한 육류 검사법(Meat Ispect Act)및 식품의약법(Pure Food and Drug Act)통과
- 최초의 약품관련 법규,최초의 식품과 의약품의 준비 및 생산을 통제하는 연방 정부 기관 탄생
2.셀리 개정(Sherley Amendment, 1912)
•소비자를 속이려는 의도로 라벨에 치료효과에 대한 잘못된 주장을 표기하는 것을 금지하는 법령 개정
3.식품의약품청FDA창성(FDA Open,1930)
•1930년 농무부 산하의 화학국 내 식품의약품관리청이 식품의약품청(FDA)으로 독립
•1955년 미국 연방 보건교육복지부 산하의 공중보건서비스(Public Health Service)소속 연방기관
•1979년 보건후생부(Department of Health and human Services)의 하부기관으로 개편
-식품과 의약품에 대한 모든 것을 관리하는 규제기관으로 발전
-현재:식품의 규격과,관련규제의 제정,영양소 기준,약품,백신,의학 및 혈액 관련 물품,의료 및 방사능 측정 기구, 화장품 등 다양한 분야의 안전규칙 제정 기관
4.미 식품-의약품-화장품 규제법령(food, Drug, Cosmetic Act,1938)
•1937년 설파닐아미드 엘릭서 사건으로 식품-의약품-화장품 규제 법령 통과
-모든 의약품 제조업자는 제품을 판매하기 전에 반드시 해당 의약품의 의약품을 표시하고 그 안전성을 입증
-FDA눈 식품,의약품 뿐만 아니라 의료기기,화장품까지 규제 확대
-1912년 셀리 개정은 삭제 됨
5.더햄-험프리 개정(The Durham-Humphrey Amendment,1951)
•의약품의 분류를 법의로 규정하고 처방약과 비처방약의 분류에 대한 기준
-분류군의 확정은FDA가 담당
-의약분업으로 의사의 처방관과 약사의 조제권 엄격히 구분 및 의무화
•1958년 델라니 조항(Deleney Clause)[식품 속 발암성 물질의 사용 일절 금지]추가
6.케파우버-해리스 개정(The Kefauver-Harris Amendment, 1962)
•1962년 탈리도마이드 사건 발생 이후 식품-의약품-화장품 법에 대한 강화된 수정안
-해당의약품이 반드시 효과가 잇다는 유효성 입증과 안전성에 관한 증거로 독성 실험 자료를 제출해야 한다는 규정: 현재IND신정 규정의 기초
-의약품 허가를 위해 실질적인FDA의 사전승인을 유구
-약물의 이상반응에 대한 의무적인 보고와 고지를 통해 위험성에 대한 발표를 요구
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