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      (A) comparison study on clinical trial regulation between Korea and China

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      https://www.riss.kr/link?id=T14741455

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      다국어 초록 (Multilingual Abstract)

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      China is the biggest emerging pharmaceutical market in the world, also an important exporter to Korea. Recently many Korean pharmaceutical companies force to China, but always encountered problems in IND process. This is related to the lack of understanding of China's clinical trial application laws and regulations by Korean pharmaceutical companies.
      For Korean pharmaceuticals incomplete data, the lack of key information, data translation errors, unreadable files, unqualified files are common problems. To understand the new policy of CFDA is the key for Korean pharmaceuticals who want to enter the Chinese pharmaceutical market or already do business in China to make it easier.
      The study was compared to clinical trial application regulations in Korea and China, give some help to the Korean pharmaceuticals in China for clinical trials. Elucidate the differences in the Chinese and Korean clinical trial regulations. To improve the application success rate, reduce the failure rate, reduce unnecessary costs and make a great strategy easier.
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      China is the biggest emerging pharmaceutical market in the world, also an important exporter to Korea. Recently many Korean pharmaceutical companies force to China, but always encountered problems in IND process. This is related to the lack of underst...

      China is the biggest emerging pharmaceutical market in the world, also an important exporter to Korea. Recently many Korean pharmaceutical companies force to China, but always encountered problems in IND process. This is related to the lack of understanding of China's clinical trial application laws and regulations by Korean pharmaceutical companies.
      For Korean pharmaceuticals incomplete data, the lack of key information, data translation errors, unreadable files, unqualified files are common problems. To understand the new policy of CFDA is the key for Korean pharmaceuticals who want to enter the Chinese pharmaceutical market or already do business in China to make it easier.
      The study was compared to clinical trial application regulations in Korea and China, give some help to the Korean pharmaceuticals in China for clinical trials. Elucidate the differences in the Chinese and Korean clinical trial regulations. To improve the application success rate, reduce the failure rate, reduce unnecessary costs and make a great strategy easier.

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      목차 (Table of Contents)

      • ABSTRACT
      • Chapter 1 Introduction
      • Background
      • Chapter 2 Literature Review
      • 2.1 Current situation of Chinese medicine market and clinical trial
      • ABSTRACT
      • Chapter 1 Introduction
      • Background
      • Chapter 2 Literature Review
      • 2.1 Current situation of Chinese medicine market and clinical trial
      • 2.1.1 Scale of China pharmaceutical market
      • 2.1.2 Current situation of Chinese clinical trials
      • 2.2 Korean medicine exports and clinical trials
      • 2.2.1 Korean medical and drug export status
      • 2.2.2 Korean clinical trials
      • Chapter 3 Method
      • Chapter 4 Research Results
      • 4.1 comparison of clinical trial regulatory system
      • 4.1.1 Regulatory Agency
      • 4.1.2. Related Laws
      • 4.1.3 Procedure
      • 4.2 The changing landscape of China`s Regulatory System
      • Chapter 5 Conclusion
      • 5.1 Conclusion
      • 5.2 Limitations of the Study
      • Chapter 6 Reference
      • Appendix
      • ABSTRACT IN KOREAN
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