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  • Standard on toxicity tests of drugs, etc.
    • Competent Ministry : Ministry of Food and Drug Safety
    • Advance Publication of Legislation : 2021-07-16
    • Opinion Submission Deadline : 2021-09-13

1. Reason for revision

The purpose is to make safe drug test environment and contribute in improvement of people’s health by reflecting recent international standards accepted by Organization for Economic Cooperation and Development (OECD) and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and by supplementing some insufficient matters in operation.


2. Main content

A. As there was no difference in definition and regulation between “No Observed Adverse Effect Level (NOAEL)” and “No Observed Effect Level (NOEL)” and there was insufficiency in operation resulting in inconsistency with actual definition, it is intended to prevent confusion by civil petitioners by making improvement (Revision of Article 2 of draft).

B. It is intended to prepare improved test standards and make safe test environment through international harmonization by adding immunophenotype tests and host resistance tests to immunotoxicity tests, by adding limit dose in carcinogenecity tests, and by correcting exposure concentration, exposure method, and test methods in inhalation toxicity tests (Revision of Appendix Tables 1, 2, 6, 7, 10, 11, and 12 of draft).

Regulatory effect assessment
  • 의약품등의 독성시험기준(규제영향분석서)_20210715.hwp [download]
Legislative proposal (draft)
  • 의약품등의+독성시험기준+행정예고안.hwp [download]