국내외 임상시험용 의약품의 치료목적 사용제도 현황

• 영문명: Regulations and Guidelines for Therapeutic Approval of Investigational Drugs
• 발행기관: 대한약학회
• 저자명: 박나영(Nayoung Park) 민세림(Serim Min) 손영후(Young Hu Shon) 남진현(Jin Hyun Nam) 권순홍(Sun-Hong Kwon)
• 간행물 정보: 『약학회지』제65권 6호, 441~452쪽, 전체 12쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2021.12.31

영문 초록

Unapproved investigational drugs have substantial uncertainty in terms of efficacy and safety. The compassionate use of investigational drugs, nevertheless, provides a patient with a serious disease or life-threatening condition a pathway to access unauthorized medications. This has gained significant traction during the Coronavirus 2019 disease pandemic. We review the laws and regulations of programs in the United States of America, Australia, the United Kingdom, and South Korea, where such programs are currently in effect, specifically on the following aspects: regulations, requirements, eligible patients, charges, and patient safety plans. Additionally, we investigated therapeutic-approval cases in South Korea from January 2016 to March 2021.

목차

서 론(Introduction)

방 법(Methods)

결과 및 고찰(Results and Discussion)

결 론(Conclusion)

References

키워드

Investigational drug Therapeutic use Compassionate use Health policy Expanded access