의약품 허가 규제 국제 협력에서의 허가참조제도

• 영문명: Study on Reference Country of Regulatory Collaboration in the Market Authorization for Pharmaceuticals
• 발행기관: 대한약학회
• 저자명: 권진원(Jin-Won Kwon) 송윤경(Yun-Kyoung Song) 이승미(Seung-Mi Lee) 박은혜(Eun-Hye Park) 시아차린가린다(Siachalinga Linda) 박희영(Hee Young Park) 공수진(Su Jin Kong) 이인향(Iyn-Hyang Lee)
• 간행물 정보: 『약학회지』제65권 제2호(2021년), 141~149쪽, 전체 9쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2021.04.30

영문 초록

This study sought to understand the current regulatory collaboration practices of reference country systems in selected countries. The study included eight countries, namely; Nigeria, South Africa, Malaysia, Vietnam, Singapore, Indonesia, Switzerland, Mexico, and two alliances;, namely European Union and ACCESS consortium. The latest data on the reference country systems in the selected countries were collected and analyzed. The reference regulatory authorities include (1) internationally recognized countries (e.g., Stringent Regulatory Authority, SRA), (2) internationally recognized collaborations (e.g. Pharmaceutical Inspection Co-operation Scheme), (3) internationally recognized programs (e.g., WHO Prequalification), and (4) mutual recognition between countries. The SRA is the most frequently mentioned reference in unilateral reference systems, which are not based on mutual recognition. A reference country system could affect regulatory processes in two ways; either by countries requiring market approval from a reference country as a condition for a new application or by reducing the period of review if an applicant submits an assessment report and relevant data reviewed by a reference country. The European Union Mutual Recognition has resulted into efficient work-flow among member states, and similar international alliances are emerging. Of these, the ACCESS consortium is seeking the possibility of a new collaboration not based on geographical region, in contrast to regional collaboration, which seems seclusive to worksharing among nonequivalent member states.

목차

서 론(Introduction)

방 법(Methods)

결 과(Results)

고 찰(Discussion)

결 론(Conclusion)

감사의 말씀(Acknowledgment)

Conflict of Interest

References

키워드

Reference country regulatory collaboration market authorization reliance recognition