A little over a hundred days after assuming the position of director-president of the National Health Surveillance Agency (Anvisa), Leandro Safatle’s mantra is to accelerate processes to continue his five-year term. To achieve this, the agency will begin looking more closely at international approvals and triple its investments in artificial intelligence (AI).
This week, around a hundred new servers arrived at the agency and their work, reveals Safatle, will be focused on reducing analysis times. In addition to this subject, the president affirms that communication is a priority area for management. In an interview with GLOBO, Safatle spoke about management challenges, manipulated weight loss pens and the “revolution” that could occur in the field of herbal medicines, medicines made from medicinal plants.
What are Anvisa’s main challenges in 2026?
We have been here for a little over a hundred days and we have clearly established a priority: reducing the queues. We just announced a series of actions to change the management of processes and people, the technological infrastructure and everything else, to try to bring that speed to the processes. We know that reducing queues is what increases access to the Brazilian population. We live in a very interesting technological development scenario, with gene therapies, advanced therapies, personalized therapies and the use of AI in a series of them. We want to have a more agile Anvisa so that these technologies reach the population of the country.
Each drug has a specific queue (to be evaluated). There are queues that should last a year and today they are taking three. What do we want to do? Let the queue last a year, in fact. When we talk about reducing queues, that’s it. It is very important to provide this predictability to the regulated sector.
Are there areas that will benefit the most?
Research. We use trusted tools, namely the regulatory conference. We will take some of the processes that are happening overseas, among those who have already obtained registration, research authorization abroad, by the FDA, by the EMA (North American and European Union agencies) and we will bring them here. We thus save more than 40% of analysis time. This has already been done, but it will be intensified. I talked about research, but in the field of registration we will also use this type of procedure.
Recent reports have highlighted that the agency will have to evaluate the registration of 20 weight loss pens and that there will be a prioritization of these, which will delay the analysis of other drugs. What does this scenario look like?
This is a precursor analysis of this project. These are optimized analyses, for example taking a specific active ingredient and performing a joint analysis of all the products it contains (that packaging). In the case of GLP-1 (Ozempic and Wegovy class of drugs), there are 20 identical products to be able to act. This saves us a lot of time in the analysis process. We have a series of instruments (to speed up processes), this is one of them.
And how will Brazilian innovations be followed?
We primarily spoke to Anvisa’s senior management to monitor the disruptive innovation processes taking place in the country. There are four products in this committee, the chikungunya vaccine from Butantan with Valneva; polylaminin (innovative medicine for cases of paralysis), Wolbachia dengue mosquitoes, already in production in Brazil, and endoprostheses. It is a committee that will monitor these innovations.
It feels like Anvisa has started to be stricter about suspending foods, supplements and cosmetics. Is this true?
More than half of the suspensions were surcharges. This was an improvement in the regulatory process. We have centralized. The surveillance system of our country is a tripartite system: it has Anvisa as the central federal body, but it also has a very important work process carried out by municipal and state visas (surveillance). What we did recently at the agency was a regulatory shift. We have taken this process of registration of food supplements to its central body, Anvisa. We evaluate and inspect those supplements that were sold in the country and those that will be sold in the country as well.
A recent federal police operation demonstrated that the manipulation of the active ingredient in Mounjaro (tirzepatide) leads to an irregular market for the sale of this weight-loss drug. Medical entities have already requested the suspension of handling of the product in Brazil. What does Anvisa intend to do about this?
The compounding pharmacy plays a very important role in serving those who need specific dosages. There was now the federal police investigating the complaints (regarding irregular Mounjaro). This is work that Anvisa has supported, as we recognize the importance of this investigation. We are in the middle of this process, we are carrying out further inspections at other pharmacies so we can track what is happening. Regulatory action will be taken if necessary.
Regulation of the cultivation of medical cannabis is also expected to take place soon in Brazil, at the end of March, as determined by the Superior Court of Justice. Which countries will we draw inspiration from?
This is a subject that we will still discuss with the board of directors, the path we take will still be discussed. However, I can say that we will respect the deadline set by the STJ.
Recently, Anvisa approved the new framework for medicinal plants. What changes with the resolution?
Until then, the standard for registering herbal medicines was very similar to that for registering synthetic medicines: take every molecule of the plant to be able to register it. But we know that a herbal medicine has a very significant synergistic effect. And the therapeutic effect comes largely from this synergy. So we weren’t considering this type of process. This is a regulatory development that the main countries of the world had already achieved. Europe uses this type of logic a lot. Germany has 10,000 medicinal plants. England has 3 thousand. China has 70,000 of these drugs. Brazil, due to its regulatory structure, has just over 300. This is given that we have the greatest biodiversity in the world. We have over 50,000 facilities here in the country that could be used in this way. This subject has been discussed here for over ten years. This involved a large part of academia, of the regulated sector. We have fantastic growth potential in this area. This could be a revolution.
About The Author
