연구보고서

주요 선진국의 의료기기 임상시험 관리제도 비교연구 및 개선방안 연구

연구보고서

등록일  2012.10.07

조회수  2014

정보 안내 표
주관연구기관 서울대학교병원 ;안원식
발행년 2009
키워드 의료기기, 임상시험, 제도
관련링크 http://www.prism.go.kr/homepage/theme/re...uLevel=110
 
주요 선진국의 의료기기 임상시험 관리제도 비교연구 및 개선방안 연구
 
수행기관 : 서울대학교병원
수행 연구원 : 안원식
기관 : 식품의약품안전처 / 의료기기안전국 의료기기안전정책과
 
 
최종연구목표
○주요 선진국의 의료기기 임상시험 관리제도 비교 연구
-주요선진국(미국, 일본, 영국, 독일, 호주, 이스라엘)의 의료기기 임상시험 관리제도 현황 파악
-선진국의 의료기기 규격관리제도와 의료기기 임상시험 연관성 파악
○국내 임상시험 제도 개선 방안 마련
-국내 임상시험 관리제도 현황 연구
-의료기기 국가표준규격에 대한 현황 파악
-선진국과 국내의료기기 규격관리제도와 임상시험 관리제도 비교 분석하여 개선 방안도출

연구내용 및 방법
○국내외 의료기기 임상시험 관리제도 현황 조사
-의료기기산업 선진국인 미국, 일본, 영국, 독일, 호주, 이스라엘을 대상으로 하기 항목 조사
- 임상시험 관리기관 및 업무, 조직 등에 관한 조사
-임상시험 신청, 임상시험계획서 사전 검토, 보완 및 승인 절차
-임상시험 이상반응 등의 보고 절차
-의료기기 임상시험 종료에 따른 보고 절차
-임상시험 실시기관 실태
-의료기기 관리제도의 국제공조를 위한 모임인 GHTF에서 제시하는 임상시험 관리제도 조사
-각국 임상시험 관리제도 특성 비교 및 장단점 조사 분석
○국내외 의료기기 규격 관리제도 현황 조사
-의료기기 규격관리 국제기구인 GHTF에서 제시하는 의료기기 규격과 관리제도 조사
-CE, FDA, 후생성 규격과 GHTF 규격 비교 연구
-식약청, 지식경제부 의료기기 규격 관리제도 현황 조사
-국가참조표준센터의 의료기기 규격 현황조사
○국내 의료기기 임상시험 관리제도 개선 방안(안) 제시
-의료기기 국제규격에 적합한 국내 의료기기 규격관리제도 초안 제시
-규격관리제도와 연계된 의료기기 임상시험 승인 절차 및 사후관리 방안(안) 제시

기대성과 및 활용방안
○의료기기 임상시험 관리제도의 국제적인 객관성 확보
-의료기기 임상시험의 국제적인 상호인증을 위한 기반 마련
-FDA와 후생성의 실사에 대비한 임상시험 관리제도 정비
○임상시험 관리제도의 개선방안 마련을 위한 자료로 활용
-향후 임상시험 관리제도 개선방안 마련을 위한 기초 자료로 활용
○국제 의료기기 규격관리 협의체 가입을 위한 자료로 활용
-의료기기 규격관리 국제기구인 GHTF에 가입하기 위한 제반 기초 자료 마련에 활용"
 
 
 
Ⅰ. 총괄연구개발과제 요약문 ···································································································· 7
Ⅱ. 총괄연구개발과제 연구결과 ······························································································11
제1장 총괄연구개발과제의 목적 및 필요성 ·······················································································11
1.1 총괄연구개발과제의 목표 ··································································································································11
1. 연구의 필요성 ························································································································································11
2. 최종 연구 목표 ······················································································································································12
1.2 총괄연구개발과제의 목표달성도 ·····················································································································13
제2장 총괄연구개발과제의 내용 및 방법 ···························································································14
1. 주요 선진국의 의료기기 임상시험 관리제도 분석 ······················································································14
2. 국내 임상시험 제도 개선 방안 마련 ················································································································14
2.2 연구 방법 ·······························································································································································15
1. 주요 선진국의 의료기기 임상시험 관리제도 분석 ························································································15
2. 국내외 의료기기 규격 관리제도 현황 조사 ····································································································16
3. 국내 의료기기 임상시험 관리제도 개선 방안 제시 ······················································································17
제3장 총괄연구개발과제의 최종결과 및 고찰 ···················································································18
3.1 국ㆍ내외 의료기기 임상시험 관리제도 현황 조사 ····················································································18
1. 국내 의료기기 임상시험 관리제도 ····················································································································18
2. 미국 의료기기 임상시험 관리제도 ····················································································································33
3. 일본 의료기기 임상시험 관리제도 ····················································································································50
4. 영국 의료기기 임상시험 관리제도 ····················································································································66
5. 독일 의료기기 임상시험 관리제도 ··················································································································84
6. 호주 의료기기 임상시험 관리제도 ····················································································································91
3.2 국내ㆍ외 의료기기 규격 관리제도 현황 조사 ··························································································108
3.3 국내ㆍ외 의료기기 임상시험 관리제도 특성 비교 ··················································································112
3.4 국내 의료기기 임상시험 관리제도 개선 방안 제시 ················································································116
1. 임상시험계획서 사전 검토 ································································································································116
2. 임상시험 신청ㆍ보완 및 승인 절차 ················································································································116
3. 이상반응 등의 보고 절차 ··································································································································117
4. 임상시험 종료에 따른 보고 절차 ····················································································································117
5. 임상시험 실시기관 실태 ····································································································································117
3.5 국내 의료기기 규격 관리제도 개선 방안 제시 ························································································118
3.6 그 밖에 의료기기 규격 및 임상시험 관리제도 개선 방안 제시 ·························································121
1. 연구용 임상시험 관리제도 도입 ······················································································································121
2. 의학연구윤리위원회(IRB)를 포함한 임상시험 질관리 제도 도입 ····························································123
3. 타당성(feasibility test) 검토 제도 도입 ········································································································126
4. 의료기기 임상시험에서 베이지안 통계법 활용 ····························································································127
5. 규격관리제도와 연계된 의료기기 임상시험 승인 및 사후관리 방안 개선책 ········································128
6. 신속한 사전 상담제도 제안 ······························································································································129
7. 의료기기 임상시험 관리제도 교육 및 홍보 방법 개선 ··············································································130
제 4장 연구개발과제의 연구성과 ·······································································································131
4.1 활용성과 ···························································································································································131
4.2 활용계획 ·························································································································································132
제 1절 각 국의 의료기기 임상시험 관리제도에 대한 현황파악과 비교 연구 ·····································132
1. 임상시험 관리기관 및 업무, 조직 ···················································································································132
2. 임상시험 신청, 임상시험계획서 사전 검토, 보완 및 승인 절차 ······························································132
3. 임상시험 이상반응 등의 보고 절차 ················································································································132
4. 임상시험 실시기관 실태 ····································································································································133
5. 각국 임상시험 관리제도 특성 비교 및 장단점을 조사 분석 ····································································133
제 2절 의료기기 임상시험 관리제도 개선 방안 ······························································································133
1. 규격 관리 제도 개선 방안 ································································································································133
2. 의료기기 임상시험 실시기관의 품질관리 ······································································································133
3. 연구용 임상시험 관리 제도 ······························································································································134
4. 타당성 검토 (feasibility test) 제도 ················································································································135
5. 의료기기 임상시험에서 베이지안(Bayesian) 통계의 활용 ········································································135
6. 사후보고제도에 대한 개선 ································································································································135
7. 사전 상담 제도의 개선 ······································································································································135
8. 의료기기 임상시험 관리제도 교육 및 홍보 방법 개선 ··············································································136
제 3절 FDA 기준 규격 및 허가 과정 심포지움 ·····························································································136
제5장 총괄주요연구 변경사항 ·······························································································································138
제6장 총괄참고문헌 ··················································································································································140