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Government Legislation

  • Partial Amendment to the Enforcement Decree of the Pharmaceutical Affairs Act
    • Competent Ministry : Ministry of Food and Drug Safety
    • Advance Publication of Legislation : 2023-07-17
    • Opinion Submission Deadline : 2023-08-28

Reasons for Amendment and Major Provisions


The Pharmaceutical Affairs Act was amended (Act No. 19359; promulgated on April 18, 2023; enforced on October 19, 2023) to establish a permanent monitoring system for illegal distribution/advertising of drugs in online spaces, and to prescribe that information and communications services providers, etc. may be requested to take certain measures in the event of a confirmed violation. Accordingly, this Amendment prescribes measures for informing consumers of advertisements to arrange the illegal distribution of drugs, institutions/organizations to be commissioned with the monitoring of illegal distribution, and other matters delegated by the Act and matters necessary for the enforcement thereof. 


It also clearly stipulates grounds to delegate reporting on the production, export, and import performance of drugs, etc., and otherwise addresses and improves upon a number of weaknesses that have emerged from the operation of the current system.


Regulatory effect assessment
  • 약사법 시행령(규제영향분석서)_20230706.hwp [download]
Legislative proposal (draft)
  • 약사법 시행령 일부개정령안_수정안(230704).hwpx [download]