• ANVISA Updates COVID Vaccine and Low-Risk Medicines Classification

    ANVISA updated the regulatory framework for COVID-19 vaccines and revised the classification of low-risk medicines, impacting regulatory requirements and product categorization.

  • Mobile?scanning & Digital?labeling Rules for Centrally Authorised Medicinal Products

    EMA CMDh finalizes guidance on mobile scanning and other technologies in the labeling and package leaflet of centrally authorised medicinal products

  • Mexico: COFEPRIS Publishes Self-Verification Guide for Inspection and Traceability of Health Supplies – Drugs

    COFEPRIS issues a self-verification guide to support compliance with sanitary inspection and traceability requirements for medicinal and herbal products, providing operational criteria to strengthen internal controls and regulatory readiness.

  • Brazil: ANVISA approves new regulatory framework for herbal medicines

    ANVISA approved a new regulatory framework simplifying registration and expanding the use of biodiversity in herbal medicines in Brazil.

  • Mexico: COFEPRIS Publishes Catalogue of Criteria and Requirements for Submitting Drug Samples for Analysis

    COFEPRIS issued a guidance document detailing the criteria, documentation, and analytical requirements for submitting pharmaceutical, biological, vaccine and API samples for laboratory analysis at CCAYAC-accredited facilities.