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