의약품 인허가 과정에서 허가참조제도에 대한 전문가 심층 의견

• 영문명: Reference Country System of Regulatory Collaboration in the Market Authorization for Pharmaceuticals; From the Perspective of Experts
• 발행기관: 한국보건사회약료경영학회
• 저자명: 이인향 권진원 송윤경 이승미 박은혜
• 간행물 정보: 『한국보건사회약료경영학회지』제10권 제2호, 79~87쪽, 전체 9쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2022.11.30

영문 초록

Each country is trying to enhance the efficiency of pharmaceutical licensing procedure by designating their own reference countries that have extensive experience in pharmaceutical regulatory affairs. This study aimed to investigate how Korea can become a regulatory advanced country that other countries can refer to in the pharmaceutical licensing procedure. Focus group or in-depth interviews were conducted with 8 pharmaceutical regulatory experts. The collected data were analyzed using the framework analysis technique. The three themes that emerged from the interviews were; the effectiveness of reference country system, possibilities and obstacles for Korea to become a reference country for other countries, and the prospect for Korea to become a reference country. The positive and negative aspects of reference country system were discussed. The possibility of Korea becoming a reference country for other countries was discussed in two ways; mutual recognition and unilateral recognition. Lastly, it was discussed that it is necessary to enhance the international status of the Ministry of Food and Drug Safety and to change the paradigm of the domestic pharmaceutical market in order for Korea to become a reference country. Based on the above results, short-term and mid-to-long-term strategies were presented for Korea to become a reference country for pharmaceutical licensing procedure as a measure to promote overseas expansion of domestic pharmaceutical companies.

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키워드

reference country pharmaceuticals regulatory collaboration market authorization reliance recognition interview