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KMID : 1142220080030010001
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Regulatory Research on Food, Drug & Cosmetic
2008 Volume.3 No. 1 p.1 ~ p.20
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Proposed guideline on the rewording and restructuring of KFDA Regulations
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Kwon Kyeng-Hee
Kim Sung-Gon
Cheong Jae-Hoon
Hwang Sung-Joo
Chun In-Koo
Moon Young-Sim
Choung Se-Young
Suh Hwal
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Abstract
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By decreasing the arbitrary interpretation of KFDA regulations, the present research intends to minimize the existing dissention between civilians and public servants of the KFDA and solve conflicts found in the KFDA Regulation that clash with the Supreme Law. The present effort is considered to have cleared the level 1 improvements successfully. With the level 2 improvement of establishing a uniform terminology between regulations and the level 3 task of unifying the regulations of each specialty and between each other, it will become possible to upgrade the approval and post-management system of food, drugs, medical devises, cosmetics and functional foods. The 109 regulations in motion at the time the present research was initiated (Feb. 23, 2007) have increased their numbers to 115. However, the present research only investigated and improved the 112 regulations modified or enacted up to June 30. The research has identified several regulatory problems of the KFDA Regulations. However, as the present research was limited to the regulations already in place, the demands received from diverse related industries regarding regulatory improvements were not included in the final report. Nonetheless, we believe that we have sufficiently expressed the current need for easier regulations, clear regulations, honest regulations and natural regulations. We expect that the criteria for“ Creating easy to know Regulations”proposed will be great aids for future modifications and enactments of KFDA regulations. We anticipate that the regulatory terminology list, the data from evidence-based laws and ordinances, the terminology handbook before and after modifications, and other data provided by the present research will serve as basic tools to assist in subsequent efforts to improve current KFDA Regulations.
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KEYWORD
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KFDA, regulation, rewording, restructuring
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FullTexts / Linksout information
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Listed journal information
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