Life Science Newsletter
Regulatory convergence has moved from rhetoric to procedure.
Mexico now recognizes Anvisa’s decisions and created a simplified drug registration pathway. It is a concrete reliance milestone in the Americas, alongside Brazil and Mexico cooperation and Anvisa’s agenda in China.
In Brazil, the direction is efficiency and digitalization: optimized review for synthetic and semi-synthetic drugs, electronic registration of foreign manufacturers (devices, cosmetics, sanitizing products), new device guidance manuals, and updated Periodic Benefit-Risk Report guidance.
Worth watching: medical cannabis, the new phase of the National Prescription Control System, analytical labs, AI in medicine (CFM), and open consultations in food and agricultural inputs.
Companies adjusting records, documentation and registration strategy now will gain time in the next cycles.
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