I. 연구개요································································································································································ 1
1. 추진배경 및 목적······················································································································1
1-1. 사업추진배경·····················································································································1
1-2. 사업추진의 목적 및 필요성 ·······························································································4
2. 사업목표 및 내용······················································································································6
2-1. 사업목표···························································································································6
2-2. 사업추진 Framework ·······································································································7
II. 국내외 규제샌드박스 추진현황 ·························································································8
1. 국내 규제샌드박스 운영 현황·····································································································8
1-1. 전체개요···························································································································8
1-2. 산업융합(산업부) 규제샌드박스··························································································11
1-3. 혁신금융(금융위) 규제샌드박스··························································································18
1-4. 규제자유특구(중기부) 규제샌드박스···················································································30
1-5. 연구개발특구(과기부) 신기술 실증특례···············································································43
1-6. 종합 및 시사점···············································································································47
2. 해외 주요국의 규제샌드박스 현황 ···························································································51
2-1. 영국의 규제샌드박스 ······································································································51
2-2. 싱가포르의 규제샌드박스··································································································79
2-3. 일본의 규제샌드박스········································································································96
2-4. 캐나다 (바이오헬스 관련 규제개선 사례) ········································································107
2-5. 미국의 획기적 의료기기 프로그램(Breakthrough Device Program) ·······························116

III. 바이오헬스 규제현황····································································································129
1. 바이오헬스 분야 규제현황 조사 (규제샌드박스 승인과제를 기반으로) ·······································129
1-1. 규제현황 조사 개요·······································································································129
1-2. 규제현황 조사 결과·······································································································133
2. 바이오헬스 분야 규제샌드박스 사례 조사 ··············································································162
2-1. 마크로젠 (실증특례) ·····································································································162
2-2. 테라젠이텍스·················································································································165
2-3. 주식회사엔에프··············································································································168
2-4. 휴이노··························································································································171
2-5. ㈜아람휴비스 (2건) ········································································································173
2-6. 국내 바이오헬스분야 규제샌드박스 사례 기반의 개선이슈 ················································175
3. 바이오헬스 분야 규제 이슈 및 개선방향 ···············································································180
IV. 바이오헬스 특화 규제샌드박스 운영전략 ······································································181
1. 바이오헬스 특화 규제샌드박스 제도 기본방향 (운영전략) ··························································181
V. 바이오헬스 특화 규제샌드박스 설계(안) ········································································187
1. 바이오헬스 특화 규제샌드박스 개요 ······················································································187
2. 바이오헬스 특화 규제샌드박스 추진체계 ················································································190
3. 바이오헬스 특화 규제샌드박스 추진절차 ················································································195
3-1. 신청단계·······················································································································195
3-2. 심사단계·······················································································································196
3-3. 승인단계·······················································································································201
3-4. 사후단계·······················································································································203
4. 바이오헬스 특화 규제샌드박스 입법(안) ·················································································212
4-1. 입법안 개요··················································································································212
4-2. 조문별 해설··················································································································214
[참고문헌] ·······················································································································253

I. 연구개요 1. 추진배경 및 목적 1-1. 사업추진배경  정부는 산업활성화를 위한 규제개혁의 일환으로 월 규제샌드박스를 도입하고 이를 ’18.1 , 점차 확대하고 있으며 현재는 국무조정실 중심의 개 부처 협업체계 , 6 (1+5)로 운영 中  정부는 규제 재설계를 통한 차 산업혁명에의 선제적 대응과 국민 개개인의 삶의 질 향상을 4 목표로 본격적인 규제개혁을 추진하기로 하고 새정부 규제개혁 추진방향 및 규제혁신 , (’17.9) 추진계획 에서는 미래 산업 규제혁파의 일환으로 규제 샌드박스 도입을 결정 (’18.1) 新  이에 년 행정규제기본법 개정과 함께 핀테크 산업융합 지역 혁신성장 개 분야 ‘19 ICT, , , 4 , ’ 년 스마트도시 연구개발특구 개 분야에 대하여 규제 샌드박스 도입을 위한 근거법을 마련 20 , 2 - 개별법 영역에서는 정보통신융합법 개정과기부 금융혁신법 제정금융위 산업융합촉진법 ( ), ( ), 개정산업부 지역특구법 개정중기부 스마트도시법 개정국토부 연구개발특구법 개정 ( ), ( ), ( ), ( ) 과기부 등 규제샌드박스를 통한 규제완화를 위한 입법 추진 * 민간협업체계로 대한상의 샌드박스 지원센터가 월 출범 운영 중이며 년 모빌리티 분야 도입을 추진중20.5 · , 2021  ’19 , , 6 년 규제샌드박스 제도는 신속확인 실증특례 임시허가로 구성되어 상기 개 분야에서 운영하고 있으며 월 기준 건 의 실증특례 건 의 임시허가 건 의 적극행정 등 , ’21.2 332 (81%) , 48 (12%) , 30 (7%) 410건의 규제샌드박스 과제를 승인하여 안정적 운영 (’21.7 481 ) 월 기준 건 - 기업규모별로 보면 중소벤처기업 건 대기업 건 중심으로 기술별 , (274 , 67%), (116 , 28%) , 로는 에너지 건 건 의료바이오 건 분야 순으로 승인 (46 ), IoT(39 ), (33 ) [그림 1] (2021.2 ) 규제샌드박스 승인현황 월 기준 - 2 -  현재 개 승인과제의 개 가 시장출시 또는 실증테스트가 진행중이며 규제샌드박 410 45%(185 ) , 스를 통해 투자 조 천억원 유치 매출액 억원 증가 고용 여명 창출의 효과 도출 1 4 , 518 , 2,800 1) [그림 2] 규제샌드박스의 경제적 효과  4차 산업혁명 생명공학 기술발전과 함께 전 세계적인 건강수요 증가로 바이오헬스 분야 , 에서 신기술을 활용한 새로운 제품 서비스 급증 ·  인구고령화 생활습관 변화 의료 재정부담 증가 등으로 바이오헬스에 대한 사회적 수요 , , 가 증가하고 있으며 특히 한국은 고령화로 인해 의료비 비중이 제일 빠르게 증가 , /GDP * 의료비 연평균 증가비율 한국 미국 일본 /GDP(2005~2017) : [ ] 3.7%, [ ] 1.3%, [ ] 2.7% [그림 3] OECD GDP 주요국의 대비 의료비 비중  이러한 사회적 수요와 함께 차 산업혁명 기술이 발전함에 따라 질병의 조기진단 맞춤형 치료에 4 , 대한 관심이 높아지면서 바이오헬스산업 기술혁신과 시장성장이 급속도로 진행