• US FDA Requests Labeling Changes for Menopausal Hormone Therapies

    Application holders of HRT/MHT to make safety-related labeling changes for clarity benefit/risk considerations.

    The regulation was released on November 10, 2025.

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    USFDA | Pharmaceuticals | Regulatory Labeling

  • Nigeria Recognizes MFDS as a Reference Agency for Vaccines

    Faster, streamlined vaccine approvals for MFDS-authorized products in Nigeria

    The regulation was released on November 11, 2025.

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    MFDS | Pharmaceuticals | Regulatory Affairs

  • MFDS Releases Guideline on Assessing Identity of Active Ingredients in Generic Drugs (Guide-1452-01)

    MFDS publishes detailed considerations for evaluating active ingredient identity in generic drugs, including data requirements, evaluation methods, and regulatory expectations.

    The regulation was released on November 11, 2025.

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    MFDS | Pharmaceuticals | Regulatory Affairs

  • MFDS Rationalizes Stability Test Data Requirements for Pharmaceutical Manufacturing Changes

    Faster, globally aligned stability data submissions for approved drugs—now reduced from 6 months to 3 months.

    The regulation was released on November 12, 2025.

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    MFDS | Pharmaceuticals | Regulatory Affairs

  • Informed Consent Applications in Mutual Recognition and Decentralised Procedures

    Regulatory issues for informed consent applications, with Article 10c of Directive 2001/83/EC allowing pharmaceutical, preclinical, and clinical documentation.

    Consult Freyr to know more

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    EMA | Pharmaceuticals | Regulatory Medical Writing