• European Pharmacopoeia Issue 13.1 Implementation Requirements

    EDQM releases European Pharmacopoeia Issue 13.1 with revised monographs and mandatory implementation timelines.

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    EDQM | Pharmaceuticals | Compliance, Audit and Validation

  • PRAC Safety-Signal Labeling Updates for Medicinal Products

    EMA PRAC mandates safety-related SmPC and PIL updates following signal assessments adopted during the April 2026 PRAC meeting.

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    EMA | Pharmaceuticals | Regulatory Labeling

  • Regulation: ANVISA Redefines Petition Codes for Package Inserts, Labels, and Names of Biological and Radiopharmaceutical Products

    The redefinition of petition codes related to package inserts, labeling, and names of biological and radiopharmaceutical products by ANVISA, including changes in the petition process and alignment with federal government principles.

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    ANVISA | Pharmaceuticals | Regulatory Affairs

  • COFEPRIS Presents the Drug Health Registration Viewer

    New digital platform providing real-time information on the validity and legality of medicines in Mexico, replacing the previous consultation mechanism.

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    COFEPRIS | Pharmaceuticals | Regulatory Affairs

  • ANVISA Manual for Importation by DUIMP (Version 1.7)

    Guidelines for importers on the process of petitioning the Single Import Declaration (DUIMP) through the Single Foreign Trade Portal, including registration, electronic signatures, and sanitary control procedures.

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    ANVISA | Pharmaceuticals | Regulatory Affairs