"Brazil: Mandatory Registration of Health and Sanitary Surveillance Units in CNES · Strengthening Regulatory Oversight, System Access & Compliance Requirements"
ANVISA Reaffirms Mandatory CNES Registration for Health and Sanitary Surveillance Units as a Prerequisite for Regulatory System Access
ANVISA | Pharmaceuticals | Regulatory AffairsBrazil: ANVISA Updates the List of Non-Prescription Medicines (MIP) – IN 404/2025
ANVISA publishes IN 404/2025 updating Brazil’s national list of non-prescription medicines (MIP), expanding OTC classifications and enabling new Rx-to-OTC opportunities.
ANVISA | Pharmaceuticals | Regulatory AffairsBrazil: ANVISA Implements Exceptional Measures to Optimize Clinical Trial and Medicinal Product Review Queues (RDC 997/2025)
ANVISA publishes RDC 997/2025 introducing exceptional and temporary measures to optimize regulatory review queues for clinical trials, marketing authorization, and post-approval submissions for medicines and biological products.
ANVISA | Pharmaceuticals | Regulatory AffairsMexico: COFEPRIS Strengthens Regulatory Framework and Simplifies Procedures for Controlled Substances
COFEPRIS publishes an Agreement introducing regulatory simplification and digital modernization measures for procedures related to narcotics, psychotropics, and chemical precursors in Mexico.
COFEPRIS | Pharmaceuticals | Regulatory AffairsColombia: INVIMA Activates Automated Module for Free Sale Certificate (CVL) Issuance
INVIMA activates a new automated InvimÁgil module for the issuance of Free Sale Certificates (CVL), streamlining export-related regulatory procedures for health-regulated products in Colombia.
INVIMA | Pharmaceuticals | Regulatory Affairs
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