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  • Administrative Pre-Announcement of Partial Amendment to the Regulations on Evaluation of Food and Drug Testing and Inspection Agency
    • Competent Ministry : Ministry of Food and Drug Safety
    • Advance Publication of Legislation : 2023-09-22
    • Opinion Submission Deadline : 2023-11-21

1. Reasons for Amendment

This Amendment aims to check compliance with matters to check using a nonconformity checklist before a fail result where the result of a test or inspection conducted under paragraph (1) is determined to be nonconforming, increase the scope of application of the sample transportation evaluation index and improve the quality control standards evaluation score formula for ease of understanding, thereby aiming to ensure the reliability of testing and inspection.



2. Major Provisions


A. Increase the scope of application (Attached Table 4 and Attached Table 5).


B. Prescribe that where the test and inspection result is nonconforming, a nonconformity checklist is to be included in a testing and inspection certificate (Attached Table 4 and Attached Forms 2 newly inserted).


C. Improve the quality control standards evaluation score formula for ease of understanding (Attached Table 5).

Regulatory effect assessment
  • 식품·의약품분야 시험·검사기관 평가에 관한 규정(규제영향분석서)_20230914.hwp [download]
Legislative proposal (draft)
  • 식품의약품분야 시험검사기관 평가에 관한 규정 일부개정고시안.hwpx [download]