• Lebanon Designates South Korea as Pharmaceutical Reference Country Based on WHO WLA Recognition

    Lebanon has officially designated South Korea as a pharmaceutical reference country, recognizing MFDS’s WHO Listed Authority status and strengthening regulatory cooperation and market access opportunities.

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    MFDS | Pharmaceuticals | Regulatory Affairs

  • MFDS Releases Casebook for Development and Consultation of Herbal Medicine Preparations in South Korea

    South Korea’s MFDS has released a casebook outlining guidelines, consultation procedures, and Regulatory expectations for the development, approval, and clinical evaluation of herbal medicine preparations.

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    MFDS | Pharmaceuticals | Regulatory Affairs

  • MFDS Releases Guidance for Clinical Trial Plan Change Approval Applications in South Korea

    South Korea’s MFDS has released guidance outlining the electronic submission process for approval of changes to approved clinical trial plans through the Drug Safety Korea portal.

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    MFDS | Pharmaceuticals | Regulatory Affairs

  • Accelerated EMA Centralized Review Timelines Under EU Pharma Reform

    EU Pharma Package introduces reduced centralized assessment timelines for medicinal product approvals.

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    EMA | Pharmaceuticals | Regulatory Labeling

  • UK Clinical Trials Regulation Amendments Enter into Force

    MHRA implements updated UK clinical trial regulations to strengthen oversight and streamline approvals.

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    MHRA | Pharmaceuticals | Compliance, Audit and Validation