• FDA Philippines Issues Draft on Classification of Pharmaceutical Products for Human Use

    Explore Updated Classification Guidelines and Reclassification Procedures for Medicinal Products in the Philippines, today!

    The draft regulation was released on October 6, 2025

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    Food and Drug Authority-Philippines | Pharmaceuticals | Country Regulatory Affairs

  • FDA issues final guidance on conducting clinical trials with decentralized elements

    This guidance provides FDA’s recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials.

    This initiative came into effect on October 17, 2025

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    USFDA | Pharmaceuticals | Regulatory Medical Writing

  • Malaysia Expands Voluntary eLabeling for Generic OTC Medicines Learn about Malaysia’s Digital Labeling Transformation for OTCs

    Malaysia’s DCA announced voluntary e-labeling for all generic OTCs as part of its strategy for digital transparency and sustainable labeling practices.

    The initiative came into effect on October 14, 2025 Ensure OTC Compliance

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    DCA | Pharmaceuticals | Regulatory Labeling

  • Act Now: New EU Pharmacovigilance Mandates Effective 2025

    EMA enforces new 2025 pharmacovigilance and E2B(R3) compliance mandates.

    This initiative came into effect on August 29, 2025

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    EMA | Pharmaceuticals | Pharmacovigilance

  • Final Deadline: EU eCTD v8.2 Becomes Mandatory on Dec 1, 2025

    From December 1, 2025, EMA will accept only EU eCTD M1 v3.1.1 and Validation v8.2 submissions.

    This initiative will come into effect from December 1, 2025

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    EMA | Pharmaceuticals | Publishing & Submissions