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http://dx.doi.org/10.12811/kshsm.2020.14.1.055

A Comparative Analysis of Barriers for Korean Pharmaceutical Companies in Global Regulatory Affairs by Company Size  

Hong, Yoon-Na (School of Pharmacy, Sungkyunkwan University)
Ha, Dong-Mun (School of Pharmacy, Sungkyunkwan University)
Publication Information
The Korean Journal of Health Service Management / v.14, no.1, 2020 , pp. 55-65 More about this Journal
Abstract
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.
Keywords
Regulatory Affairs; Regulatory Barriers; Comparative Analysis;
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