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KMID : 0379519990150030275
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한국독성학회지
1999 Volume.15 No. 3 p.275 ~ p.288
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Main Issues of Safety Evalution for New Drug Development (Ⅰ): Regulatory Affairs and Practical Considerations at Pre-clinical Toxicity and Toxicokinetic Study
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Moon Byoung-Seok
Cho Dae-Hyun
Song Keun-Seog
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Abstract
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In the recent years, many changes were implemented for the pre-clinical and clinical study according to the international trend of harmonization in methodology of the safety assessment and efficacy evaluation on new chemical entity and biological products. The triggers happened in the medicinal field such as mistakes in the formulation of children’s syrup, thalidomide tragedy, etc. lead to establish the system for the product registration. After the I970s there was a rapid increase in laws, regulations and guidelines for evaluating and submitting data on the quality, efficacy and safety of new medicinal products. According to the globalization of market, regulatory authorities and industrial agencies have met the demand to harmonize several aspects in the course of new drug development and marketing approval. In the 1980s European Union moved to harmonization of regulatory affairs and consequently achieved a single market. International Conference on Harmonization (ICH) was born under this trend to achieve the harmonization of the technical requirement for the new drug development and completed its first phase activities. This article is intended to review the current regulatory affairs and practical considerations for the new drug development specifically in safety aspects.
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KEYWORD
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Toxicity study, Toxicokinetics, Regulatory affairs, New drug development, International Conference on Harmonization(ICH), Safety topics
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