The Korean Journal of Health Service Management (보건의료산업학회지)

Korea Society of Health Service Management (보건의료산업학회)
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A Comparative Analysis of Barriers for Korean Pharmaceutical Companies in Global Regulatory Affairs by Company Size

기업 규모별 의약품 해외 인허가 과정에서의 장애요인 비교분석

  • 홍윤나 (성균관대학교 약학대학) ;
  • 하동문 (성균관대학교 약학대학)
  • Received : 2019.11.04
  • Accepted : 2020.03.16
  • Published : 2020.03.31
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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.

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