MFDS Proposed Partial Revision of Regulations on the Safety of Pharmaceuticals

Amendment To The Clinical Trials Regulation (ctr) On Investigational Medicinal Products (imps) Labelling
Korea Ministry of Food and Drug Safety (MFDS) proposed a partial revision to Regulations on the Safety of Pharmaceuticals through Safety Notice No. 2023-333. Below is a summary of the proposed draft:
  • Expanding the scope of recognition of data submitted for registration of raw material drugs (Articles 15 and 16)
  • The data submitted on the manufacturing site of the raw material drug at the time of registration of the raw material drug will be expanded to include data certifying that the manufacturing and quality control standards of the raw material drug are appropriate, or data recognized by the MFDS as a manufacturing certificate or an equivalent as such.
  • Regulations on Procedures and Methods for Approval of Therapeutic Use of Investigational New Drugs Overseas ((Article 28(2))
  • As the scope of investigational new drugs subject to approval for therapeutic use has been expanded to include overseas new investigational medicines, regulations on application procedures and submission documents have been prepared.
  • Regulation of matters other than minor changes that do not require GMP change approval (Article 48.3)
  • As the targets for minor changes are minimal and the targets for change approval are broad, significant changes that may affect the quality of the drug are determined to be other than minor changes and are subject to change approval.
  • Regulations on Labeling Methods and Standards for Drugs and Non-Drugs for the Visually and Hearing Impaired ( Articles 71(2), 75(2), and 75(3))
  • As it is now mandatory to mark Braille and audio-visual conversion codes on drugs and quasi-drugs prescribed by the MFDS for the visually and hearing impaired, the regulations provide for methods and standards for such markings, as well as the contents and methods of surveys and evaluations on whether they are appropriate.
  • Regulations on Methods and Procedures for Online Monitoring of Illegal Sales of Drugs (new Article 71.3)
  • As the grounds for entrusting online monitoring of illegal sales of medicines have been established, regulations on monitoring methods and procedures have been prepared.
Public consultation is open until September 11th, 2023.
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