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KMID : 1002520200140010055
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Korean Journal of Health Service Management
2020 Volume.14 No. 1 p.55 ~ p.65
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A Comparative Analysis of Barriers for Korean Pharmaceutical Companies in Global Regulatory Affairs by Company Size
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Hong Yoon-Na
Ha Dong-Mun
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Abstract
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Objectives: To provide guidance for agency planning by identifying barriers faced by Korean pharmaceutical companies in global regulatory affairs.
Methods: A questionnaire survey on global regulatory affairs was administered by email to personnel at Korean pharmaceutical companies. From a total of 60, 28 responses were collected. Respondents’ companies were classified as small-sized or large-sized, based on whether their annual sales amounted to KRW 100 billion.
Results: Small-sized companies were experiencing greater difficulties in receiving drug approvals from advanced countries, particularly during the Investigational New Drug (IND) and Good Manufacturing Practice (GMP) processes.
Conclusions: Support measures to specifically help small-sized companies enter more advanced markets and further improved global regulatory guidelines that can meet large-sized companies’ expectations are needed. Moreover, domestic and global regulatory standards should be harmonized to benefit both groups.
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KEYWORD
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Regulatory Affairs, Regulatory Barriers, Comparative Analysis
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