• Colombia: INVIMA Activates New Functionality for CVL Generation with Observations in InvimÁgil

    INVIMA activates a new InvimÁgil functionality enabling the issuance of Certificates of Free Sale with observations, enhancing digital regulatory operations and certificate management in Colombia.

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    INVIMA | Pharmaceuticals | Regulatory Affairs

  • Mexico: COFEPRIS Recognizes 2025 Advances of the Permanent Commission of the Mexican Pharmacopoeia

    COFEPRIS acknowledges the 2025 advances of the Permanent Commission of the Mexican Pharmacopoeia (FEUM), highlighting continued progress in strengthening official quality standards for medicinal products in Mexico.

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    COFEPRIS | Pharmaceuticals | Regulatory Affairs

  • Brazil: CIOMS Publishes Guidance on the Use of Artificial Intelligence in Pharmacovigilance

    CIOMS publishes guidance on the responsible and transparent use of artificial intelligence in pharmacovigilance, reinforcing governance, data integrity, and regulatory alignment.

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    ANVISA | Pharmaceuticals | Regulatory Affairs

  • Brazil: ANVISA Approves Requirements for Electronic Prescriptions of Controlled Medicines

    ANVISA approves regulatory requirements for electronic prescriptions of controlled medicines, strengthening digitalization, traceability, and regulatory oversight in Brazil.

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    ANVISA | Pharmaceuticals | Regulatory Affairs

  • Brazil: ANVISA Leads Development of ICH M18 Guideline

    ANVISA approves a concept document to guide the development of the ICH M18 guideline, reinforcing Brazil’s leadership in international regulatory harmonization for medicinal products.

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    ANVISA | Pharmaceuticals | Regulatory Affairs