Anvisa creates working groups to evaluate weight-loss pens

Teams will have deadlines of 45 and 90 days to examine risks and patterns of use of substances used for weight loss

Anvisa (National Health Surveillance Agency) established two technical teams to examine the use and risks of calls “slimming pens” —GLP-1 receptor agonist drugs— in the country. The decision was published in Official Gazette of the Union this Thursday (April 16, 2026).

The groups will have deadlines of 45 and 90 days to gather data on prescriptions, adverse effects and patterns of use of these substances, with the aim of supporting future regulatory decisions.

The measure represents a change in the regulatory agency’s approach to the topic and is part of a broader action plan to combat irregularities in the import and handling of these pens in Brazil.

Instead of adopting isolated actions, Anvisa is seeking a broader understanding of how these medicines are used in the national territory. The initiative aims to structure more precise guidelines for healthcare professionals and, eventually, make adjustments to the standards that regulate the use and monitoring of these products.

The decision comes at a time of movement in the sector, marked by the attempt to enter new manufacturers after the expiration of the patent for semaglutide, a substance used in medicines such as Ozempic and Wegovy.

TECHNICAL ANALYSIS

The (PDF – 98 k) and (PDF – 94 kB) formalize the creation of the teams. The first, with an initial term of 45 days, will be responsible for examining scientific evidence, information on the use of medicines and pharmacovigilance data. This group must identify risks, uncertainties and gaps in available knowledge. At the end, it will prepare technical recommendations for Anvisa’s board of directors. The team will be made up of representatives from the Federal Pharmacy Council, the CFM (Federal Council of Medicine) and the CFO (Federal Council of Dentistry).

The second team, established by ordinance 489/2026 and with an initial deadline of 90 days, will be responsible for monitoring and evaluating the execution of an action plan related to these drugs. Its functions include monitoring results, identifying challenges and proposing improvement measures. The work will involve the participation of a member and an alternate from each Anvisa board, with biweekly meetings. The group will also be responsible for preparing technical subsidies. Both teams have a consultative nature and must consolidate reports at the end of their activities.

The decision affects manufacturers, healthcare professionals and patients who use these medicines, as well as doctors responsible for prescribing. The results produced by the two teams will serve as a technical basis for future decisions by the regulatory agency. Among the aspects that may be examined are prescription criteria, risk communication strategies and ways of monitoring adverse effects.

HOW MEDICINES WORK

Medicines known as “slimming pens” belong to the class of GLP-1 receptor agonists. These substances imitate a hormone produced in the intestine that acts to control glucose and regulate appetite. By delaying stomach emptying and acting on areas of the brain linked to satiety, they help reduce food intake. They are indicated for the treatment of type 2 diabetes and, in specific situations, obesity.