Earticle

초록

영어

Background: For Korean pharmaceutical industry to continue to grow, it is requisite to enter the global markets of developed countries. However, the export volume has fallen short of 10% of the gross sales and the industry has only recently warming up to prepare the globalization along with suchlike the Columbus Project. Purpose: This research was conducted to identify the difficulties Korean pharmaceutical companies perceived and to discover the gap in the needs for the government aid the companies have been seeking in the purpose of entering the developed pharmaceutical markets. Method: A survey method was used for this research. Six experts were surveyed and provided comments for the pre-questionnaire. Then, a final questionnaire was developed consisting of 10 items on regulatory-related and another 10 items on non-regulatory-related factors in drug exportation using the Likert scale (1 to 5). The survey sample was 30 Korean companies which have participated in the Columbus Project since 2010. Results: Nineteen (63%) companies responded to the survey. Most companies perceived difficulty (mean = 4.19) over the entire pathway of the regulatory process of global markets. Clinical trials and post-marketing surveillance were remarked as the most difficult barrier to follow the regulatory globalization. Among non-regulatory related factors, marketing, arranging a distribution network, obtaining experts, and projecting a timeline in exportation were brought up as the most difficulty. Conclusion: Especially, cost and language barrier were considered as the main cause producing these difficulties across regulatory and non-regulatory processes and accordingly, securing both long term budget and experts at governmental level was suggested by the domestic pharmaceutical companies.

목차

Abstract
 연구 배경
 연구 방법
  설문지 개발 과정
  연구 대상
  연구 분석
 연구 결과
  선진시장 수출 시 한국기업이 봉착하는 인허가 관련 해결과제와 극복방안
  인허가 절차 외의 요인 중에서 한국 기업의 당면 과제와 지원방안
  구체적 해결과제와 지원방안의 그룹핑 결과
 고찰
 결론
 감사의 말씀
 참고문헌

키워드

저자

• 윤수진 [ Sujin Yun | 성균관대학교 임상약학대학원 보건사회약학과 ]
• 민지혜 [ Jihye Min | 한림대학교 강남성심병원 ]
• 조은 [ Eun Cho | 숙명여자대학교 약학대학 ] Correspondence to

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  한국임상약학회지 [Korean Journal of Clinical Pharmacy]

• 간기

  계간

• pISSN

  1226-6051

• 수록기간

  1991~2026

• 등재여부

  KCI 등재

• 십진분류

  KDC 518 DDC 615