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KMID : 1022920220100020079
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Journal of Korean Academy of Social & Managed Care Pharmacy
2022 Volume.10 No. 2 p.79 ~ p.87
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Reference Country System of Regulatory Collaboration in the Market Authorization for Pharmaceuticals; From the Perspective of Experts
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Leed Iyn-Hyang
Kwon Jin-Won
Song Yun-Kyoung
Lee Seung-Mi
Park Eun-Hye
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Abstract
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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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KEYWORD
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reference country, pharmaceuticals, regulatory collaboration, market authorization, reliance, recognition, interview
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