공중보건 위기대응 의료제품의 개발 촉진 및 긴급 공급을 위한 특별법 고찰 및 FDA와 EMA의 유사 법안 비교 분석

• 영문명: Public Health Emergency Preparedness and Response by Regulatory Authorities in South Korea, United States, and Europe
• 발행기관: 대한약학회
• 간행물 정보: 『약학회지』제66권 제3호(2022년), 125~139쪽, 전체 15쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2022.06.30

영문 초록

Since the outbreak of the new strain of coronavirus (SARS-CoV-2, COVID-19) was first reported, regulatory authorities worldwide have issued various regulatory guidelines and recommendations. Global authorities are committed to supporting developers of potential vaccines and treatments for COVID-19. This study reviewed the guidelines and regulatory procedures instituted by authorities in the United States and Europe to understand the current perspectives of regulatory agencies worldwide and derive implications for public health emergency responses. The Act on Encouragement of Development and Emergency Circulation of Medical Countermeasures for public health emergencies enacted in 2021 established the Ministry of Food and Drug Safety (MFDS) to oversee policies for public health emergencies. In the US, the Public Law 113-5, the PHS Act, the PREP Act and the FD&C Act grant authorities emergency use power with respect to medical countermeasures needed during public health emergencies. The FDA can also facilitate the use of those medical countermeasures. The EMA has accelerated regulatory procedures in place for expediting the development and approval of medicinal products for COVID-19. The EMA’s rapid procedure includes rolling review, accelerated assessment and conditional marketing authorisation. Based on the review of foreign policies and practices regarding public health emergencies, this study showed that the Act on Encouragement of Development and Emergency Circulation of Medical Countermeasures for public health emergency responses has made important advances in public health emergency preparedness and response.

목차

서 론(Introduction)

방 법(Methods)

결과 및 고찰(Results and Discussion)

결 론(Conclusion)

감사의 말씀(Acknowledgment)

Conflict of Interest

References

키워드

Ministry of Food and Drug Safety Medical Countermeasures Public health emergency Emergency Use Authorization Rapid procedure