On August 25, 2025, the Official Gazette of the Federal Government published Order No. 97 issued by ANVISA’s Collegiate Board, establishing stricter rules for the importation and compounding of Active Pharmaceutical Ingredients (APIs) acting as GLP-1 receptor agonists, particularly liraglutide (Saxenda), semaglutide (Ozempic, Wegovy, and Rybelsus), and tirzepatide (Mounjaro).

According to Order No. 97/2025, the importation of GLP-1 receptor agonist APIs obtained through biotechnological processes, for the purpose of pharmaceutical compounding, will only be allowed when carried out by manufacturers whose APIs have already been reviewed by ANVISA during the product’s registration process.

For GLP-1 receptor agonist APIs obtained synthetically, importation will be permitted as long as the drug containing the molecule is registered in Brazil, regardless of whether a specific analysis was conducted during the registration process.

The order also makes it mandatory for importing companies to perform the minimum quality tests set forth in Annex I of Technical Note No. 200/2025/SEI/GIMED/GGFIS/DIRE4/ANVISA. In addition, it requires compliance with existing sanitary regulations by importers and distributors, along with intensified inspection measures.

The measure aims to safeguard public interest and population health, given the high sanitary risks associated with compounding these APIs, by enforcing minimum quality control tests. In this regard, the order also removes the automatic suspensive effect (ope legis) of any administrative appeals, underscoring the priority of protecting public health.

Link: https://www.in.gov.br/en/web/dou/-/despacho-n-97-de-22-de-agosto-de-2025-650500119

Authors: Viviane Kunisawa, Mariana Cuzziol and Estela Alves