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KMID : 1142220140090020095
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Regulatory Research on Food, Drug & Cosmetic
2014 Volume.9 No. 2 p.95 ~ p.102
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ICH Activities of Ministry of Food and Drug Safety for Regulatory Harmonization
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Song Young-Mi
Park Eun-Hye
Kim Eun-Kyung
Choi Sun-Hee
Park Hee-Young
Park In-Sook
Lee Sun-Hee
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Abstract
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The International Conference on Harmonization (ICH) was established with a goal of developing and widely implementing guidelines to enhance efficiency in developing medical products. The ICH is comprised of drug regulatory authorities and pharmaceutical trade associations of the European Union, Japan and the United States and observers. After two decades of its foundation, the ICH has been expanded to a framework bringing together regional harmonization initiatives (RHIs) such as Asia-Pacific Economic Cooperation (APEC), the Association of Southeast Asian Nations (ASEAN), the Gulf Cooperation Council (GCC), the Pan American Network on Drug Regulatory Harmonization (PANDRH), the South African Development Community (SADC), the East African Community (EAC) and Drug Regulatory Authorities (DRAs) and Department of Health (DoH) of Korea, Australia, India, Singapore, Brazil, Chinese Taipei, China and Russia. With the growing importance of international cooperation for regulatory harmonization, the RHIs and DRAs/DoH have been invited to join in discussions for regulatory harmonization in pharmaceuticals. In 2007, Ministry of Food and Drug Safety (MFDS), the then Korean Food and Drug Administration (KFDA), first participated in the ICH meeting as a DRA in Korea and a deputy representative of the APEC. Since then, Korea has contributed to promoting international cooperation for regulatory harmonization by continuously participating in various ICH activities. One of the best examples is that Korea became the chair of International Pharmaceutical Regulators Forum (IPRF) Biosimilars Working Group. Also, MFDS has involved in nine (9) ICH Expert Working Groups (EWG) which are structured to develop and revise ICH guidelines and Questions and Answers. The participation in EWGs has given MFDS chances to reflect its country's situation in the ICH process and rapidly inform the Korean pharmaceutical industry with international technical trends.
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KEYWORD
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International Conference on Harmonization (ICH), Guideline, Ministry of Food and Drug Safety, Expert Working Group
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