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KMID : 1142220110060010029
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Regulatory Research on Food, Drug & Cosmetic
2011 Volume.6 No. 1 p.29 ~ p.51
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Comparative Study of ICH Guidelines and Domestic Guidelines on Safety
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Choi Ji-Young
Yoon Seo-Young
Woo Tae-Seon
Chun In-Koo
Cheong Jae-Hoon
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Abstract
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We compared the 16 ICH safety guidelines to that of Korean national regulations, and proposed the regulatory affairs that need to be improved and/or revised. The objective of this research project was to compare the 16 ICH safety guidelines to that of corresponding national regulations and to propose which regulatory affairs need to improved and/or revised. The ICH safety guidelines studied were those for carcinogenicity(S1A,S1B,S1C(R2)), genotoxicity(S2A,S2B,S2(R1)), toxicokinetics(S3A,S3B), chronic toxicity(S4), toxicity to reproduction & male fertility(S5(R2)), preclinical safety evaluation(S6,S6(R1)), safety pharmacology studies(S7A,S7B), immunotoxicity (S8), non-clinical evaluation for anticancer pharmaceuticals(S9), non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals(M3(R2)). The corresponding national safetyrelated regulations compared were standards of toxicity tests for drugs and quasi-drugs(KFDA Notice No. 2009-116), testing guidelines of general pharmacology for drugs and quasi-drugs(KFDA Notice No. 2009-72), regulations of approval & registration for drugs and quasi-drugs(KFDA Notice No. 2009-42), standards of non-clinical tests(KFDA Notice No. 2009-102), guidelines of non-clinical trial evaluation for investigational new drug(IND) & new drug application(NDA) (2008). We suggested that it was necessary to improve standards of toxicity tests for drugs and quasi-drugs(KFDA Notice No. 2009-116), and regulations of approval & registration for drugs and quasidrugs(KFDA Notice No. 2009-42) for the conduct of human clinical trials and marketing authorization for pharmaceuticals. If the proposed revisions can be applied to the current domestic drug screening regulations, relevant international schemes can be harmoniously established and the international competitiveness of the pharmaceutical industry can be strengthened, which is in turn contributes to the improvement of public health.
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KEYWORD
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Safety, ICH, guideline, regulation, improvement
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