Newsletter Life Sciences

Check out the June newsletter for the regulatory highlights impacting the healthcare, pharmaceutical and medical device sectors. Anvisa began the month by modernizing the issuance of certificates for registered and notified products, making the process digital, fast, and automated. It then published its 8th Annual Clinical Research Report, with relevant data on clinical trials, rare diseases, and access to care. In the field of pharmacovigilance, a rule requiring prescription retention and stricter control of GLP-1 agonist drugs, such as Ozempic and Mounjaro, came into force due to their off-label use for weight loss.

The agency also warned that compounding pharmacies are prohibited from producing intradermal fillers, as they are high-risk medical devices, and promoted the cancellation of notifications for in vitro diagnostic products that were not reclassified under the new rules. Also in June, it approved the use of Mounjaro for the treatment of obesity and overweight with comorbidities, expanding its indication beyond type 2 diabetes. In the area of foreign trade, Anvisa published RDC 977/2025, integrating itself into the DUIMP system and modernizing the control of imports and exports. Finally, the Ministry of Agriculture celebrated the opening of the Eurasian Economic Union market for the export of animal drugs, strengthening Brazil’s position as a global supplier of biological inputs.

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