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신약개발을 위한 안전성평가의 쟁점 (Ⅰ): 전임상 독성 및 독성동태시험 관련규정과 실제 고려사항
문병석(Byoung Seok Moon),송근석(Keun Seog Song),조대현(Dae Hyun Cho) 한국독성학회 1999 Toxicological Research Vol.15 No.3
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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