01/15/2026 | Vilhena Soares | Jota

 https://www.jota.info/saude/anvisa-tem-eficiencia-como-desafio-de-2026-e-busca-agilidade-regulatoria 

The main objective is to reduce the backlog of applications, whether for research authorization or for the registration of medicines and products

The Brazilian Health Regulatory Agency (Anvisa) will face urgent regulatory challenges throughout 2026. The main objective will be to continue the strategy, begun in the previous year, to reduce the backlog of applications, whether for clinical research authorization or for the registration of medicines and products.

But there are other important issues, such as updating the rules for hospital construction projects and advanced therapies. The regulation of medical cannabis cultivation and the impasse over drug and food advertising in the Supreme Court (ADI 7788) are also on the list of highlights.

The agency's collegiate board meetings begin on January 28.

In addition to these challenges, the end of Director Rômison Mota's term in December will leave a seat open on the Collegiate Board (DICOL), which will be filled in 2026. Today, the fourth board position is temporarily occupied by Marcelo Matos Moreira, a career civil servant at the agency.

Reducing queues
In November, Anvisa announced a series of actions to speed up the analysis of clinical research and registration applications for drugs and biological products.

The set of measures includes differentiated drug analysis strategies, such as grouping products that have the same technical/clinical report and the same Active Pharmaceutical Ingredient (API), in addition to expanding the use of regulatory trust.

Monitoring
In 2026, the agency is expected to monitor the performance of the measures. There are also expectations for the adoption of new tools that will reduce product review times.

Anvisa has begun forming two working groups, which will include industry representatives and experts on the subject, who will work with agency directors to evaluate the effectiveness of the package of measures adopted.

“Queues are an important issue for the entire sector, and these actions reflect the new board's concern for the national industry. The smooth implementation of these measures will be essential to bring agility, while also maintaining technical rigor,” says Fernando de Rezende Francisco, executive manager of the Brazilian Association of Clinical Research Organizations (ABRACRO).

Cannabis
By order of the Superior Court of Justice (STJ), Anvisa has until March 31, 2026, to establish, in partnership with the Ministry of Health, the rules for the cultivation of cannabis for medicinal use.

The initial deadline was September 30, 2025. The deadline was extended in light of arguments presented by the agency's director, Thiago Campos, who claimed that more in-depth studies were needed.

“We want measures that, in addition to patient safety, will reduce judicialization,” he said at a collegiate meeting that discussed the issue.

Flexibility
With the postponement, entities representing patients who use medical cannabis are hopeful that they will be heard in the coming months through meetings and public consultations.

The groups also believe that future regulations may be more flexible, going beyond the STJ's determination, which asked Anvisa to define rules only for industrial hemp (a variety of cannabis with a THC content of less than 0.3%).

Advertising of medicines and food
Anvisa is also expected to take a position in 2026 on the Direct Action of Unconstitutionality (ADI 7788) in the Federal Supreme Court (STF).

The case concerns the challenge of two Collegiate Board Resolutions, RDC 24/2010 (on advertising foods rich in sugar, salt, and fat and beverages with low nutritional content) and RDC 96/2009, with rules for advertising medicines.

In November, Anvisa, the Brazilian Association of Radio and Television Broadcasters (ABERT), which is the plaintiff in the case, and industry entities and civil society organizations interested in the issue participated in a hearing to discuss the matter.

No agreement was reached, and the ADI was suspended until February 2026.

Review
Anvisa is considering revising the rules and conducting a Regulatory Impact Analysis (RIA) on the issues.

The strategy is supported by entities in the pharmaceutical and consumer protection sectors, but is criticized by ABERT, which defends the role of the National Council for Advertising Self-Regulation (Conar) in overseeing the advertising of medicines and food.

Rules for hospitals
The revision of Anvisa's Collegiate Board Resolution (RDC) 50, which deals with the standards to be followed in physical projects for Healthcare Facilities (EAS), such as hospitals, clinics, and health centers, and which has been requested by the healthcare sector for years, is expected to take place in 2026.

In 2025, the matter was under the care of Director Rômison Mota, who ended his term in December.

Anvisa has not yet determined who will inherit the issue, but agency directors have already emphasized that the revision of the rules is seen as a priority.

Tests in pharmacies
Anvisa wants to adjust Collegiate Board Resolution (RDC) 978/2025, which establishes the requirements for the operation of services that perform Clinical Analysis Tests. The rules have been the target of complaints from the clinical laboratory and pharmacy sector.

Director Daniela Marreco Cerqueira has already stated that it is necessary to dialogue with the sector about aspects of the resolution. One of them is the definition of warehouses: places that receive samples but do not perform any type of processing/analysis, in addition to the definitions for home collection.

Anvisa has already requested data from pharmacies to understand how the rules are working in the real world. Marreco believes that, in the best-case scenario, updates should occur in March 2026.

However, discussions may be extended if the agency identifies more complex problems.

Clinical research
After the revision of the rules governing clinical research in Brazil, which resulted in Collegiate Board Resolution (RDC) No. 945/2024, the sector is still awaiting the publication of a Normative Instruction (IN) that complements the new regulations.

In December, during the last collegiate meeting of 2025, the directors decided to open a public consultation to discuss the IN, which will detail how and what the technical criteria and specific documents are for compliance with the new rules, such as submission requirements (documents) and details of the communication flow between Anvisa and the research centers.

Anvisa should present the data collected and analyze what changes should be adopted in 2026.

“This IN is essential for the standard to be fully effective. The complete regulation of this milestone is essential to ensure more predictability for clinical studies, reduce deadlines, and strengthen the innovation capacity of the pharmaceutical sector in Brazil,” says Reginaldo Arcuri, executive president of Farmabrasil.

Advanced therapies
Anvisa has included in its regulatory agenda for the 2026/2027 biennium the update of RDC No. 506/2021, which establishes the rules and guidelines for clinical research with advanced therapy products. The goal is to reduce the current requirements demanded by the agency for investigation and monitoring plans and adapt them to the emergence of new technologies.

Adaptation
The revision of the rules is considered essential, especially in view of the need to adapt to Law No. 14,874/2024, which establishes the new legal framework for research involving human subjects.

According to the sector, the rules for importing products are the biggest obstacles to research in this area and need to be updated urgently.