Anvisa may approve eight more weight-loss pens in 2026 and wants to combat products from Paraguay

Of the 24 pens included in the prioritization notice published in August last year, six have already received registration and five have had their requests denied.

Currently, another 13 requests are still being analyzed. One of them should have its evaluation completed this month and, according to Anvisa, has good prospects for approval. Another seven processes, whose analysis began this semester, should be completed by December.

Five additional requests are still awaiting evaluation and are expected to enter the queue in the coming months or early 2027.

The information was presented by Anvisa's CEO, Leandro Safatle, and the agency's directors during a meeting with journalists this Tuesday (4).

To speed up analyses, Anvisa adopted an optimized evaluation model, in which technical teams simultaneously analyze different registration requests, increasing productivity without compromising technical rigor.

Safatle stated that Brazil currently has the largest number of regularized weight loss pens among the main international regulatory agencies.

In the CEO's opinion, the increase in the number of authorized manufacturers should expand supply and reduce prices.

"When you increase competition, you generate new regularized entrants, with products whose effectiveness, safety and quality have been evaluated by Anvisa. This tends to reduce prices, expand access and occupy a large part of the space currently explored by the irregular market", he stated.

Regularization is also seen by the agency as a strategy to combat smuggling and the sale of unregistered products.

SIEGE OF THE ILLEGAL MARKET

In parallel with the increase in the supply of regulated medicines, Anvisa claims to have reinforced supervision over compounding pharmacies, distributors and importers of active pharmaceutical ingredients used in the production of these substances.

The main concern, according to Safatle, are slimming pens smuggled from Paraguay.

As Folha de S. Paulo showed, Brazilian influencers, ex-BBBs, actresses and singers used Instagram to promote Paraguayan laboratories and weight-loss pens without registration with Anvisa. However, there is no request for analysis or approval by the Brazilian regulatory agency.

According to the agency, many of these products enter Brazil without any sanitary control and are transported in inadequate conditions of conservation, including hidden inside vehicle tires, without refrigeration.

Furthermore, Safatle points out that there are pens on the market with incorrect concentrations of the active ingredient or impurities capable of causing serious damage to health. He pointed out that there are records of patients admitted to intensive care units after using these irregular products.

The agency's assessment is that the most effective way to reduce this market is to increase the availability of registered medicines, at more affordable prices, while maintaining inspection operations in partnership with the Federal Police, the Federal Revenue Service and the Federal Highway Police.

According to Safatle, recent resolutions published by Anvisa also strengthened the actions of inspection bodies at borders, allowing more rigorous actions against unregistered products.

As part of this strategy, Anvisa is in the final stage of negotiations to sign a new memorandum of understanding with the Paraguayan health authority.

The agreement provides for permanent exchange of information, data and experiences to facilitate the identification of irregular products and monitor medicines sold in the border region.

According to the agency, the cooperation will make it possible to more quickly identify products authorized only in Paraguay, but not registered in Brazil, in addition to medicines that have not even been officially launched on the international market, but are already circulating illegally.

During the conversation, Anvisa also announced that it had put into practice a plan with 125 measures aimed at reducing analysis queues.

A real-time monitoring panel was created to monitor processes daily, allowing quick adjustments in team management.

As a result, the agency has completely eliminated liabilities for radiopharmaceuticals, in vitro diagnostic products, and medical equipment. Currently, only the queue of materials for medical and orthopedic use remains among the medical devices.

The queue considered most challenging is that of synthetic medicines. Safatle points out that, in the past, products could be held in queues that lasted 3, 5 or even 10 years.

The goal is to practically eliminate all historical liabilities by December of this year or by the first quarter of 2027, meaning that the agency will only work within the legal analysis deadlines.

Among the initiatives adopted is the so-called registration mission, which deployed around 138 employees from different areas to work exclusively on analyzing registration processes during the second semester.

The agency also received reinforcements from approximately 114 new employees approved in a public competition. The new servers have already helped with analyzes for the second half of the year, which could further speed up queue reduction.

Even so, Safatle stated that the staff remains small, with around 1,600 employees. He assessed that the number is small compared to other agencies around the world. In South Korea, for example, there are approximately 3,000 employees.

For the first time, according to Anvisa, the number of completed processes began to exceed the number of new requests filed, allowing an effective reduction in accumulated stock. Anvisa, however, did not disclose the number of entries.