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Government Legislation

  • Draft for establishment of Notification on the Designation and Operation of Educational Institution for Pharmaceutical Product Safety Control Managers
    • Competent Ministry : Ministry of Food and Drug Safety
    • Advance Publication of Legislation : 2021-06-14
    • Opinion Submission Deadline : 2021-07-05

(1) Detailed matters, such as content of education of Pharmaceutical Product Safety Control Manager and the method and procedure of operation, etc., delegated by the Rules on the Safety of Pharmaceutical Products, etc. (Ordinance of Prime Minister) are prescribed.

(2) As detailed matters such as content of education of Pharmaceutical Product Safety Control Managers and method and procedure of operation, etc. are prescribed in addition to the matters prescribed in the Ordinance of the Prime Minister, it is expected that clarification will be made, and that post-sale safety control will be strengthened through the systematic and professional education of safety control managers.


Regulatory effect assessment
  • 의약품 안전관리책임자 교육기관 지정 및 운영 등에 관한 규정 제정안(규제영향분석서)_20210604.hwp [download]
Legislative proposal (draft)
  • 「의약품 안전관리책임자 교육기관 지정 및 운영 등에 관한 규정」고시 제정(안)_최종.hwp [download]