06/18/2026  |   Wallace Graciano  |  O Tempo

https://www.otempo.com.br/politica/2026/6/18/anvisa-aprova-novos-testes-de-medicamentos-em-humanos.amp 

The agency authorizes clinical trials by companies such as Pfizer, Roche, and Merck for the development of experimental treatments in Brazil.

The Brazilian Health Regulatory Agency (Anvisa) has approved a series of requests to conduct and modify human trials (clinical trials) for various experimental drugs. The decision was formalized by Resolution RE No. 2,414, published in the Federal Official Gazette on Wednesday, June 17, 2026.

The measure, signed by the Coordination of Clinical Research on Medicines and Biological Products, authorizes major pharmaceutical companies to continue or initiate new phases of scientific studies in the country. The approval covers everything from modifications to products already under investigation to authorization for new development dossiers.

Authorized Drugs and Companies
Anvisa’s resolution includes a diverse list of substances intended for the treatment of various health conditions. Among the highlights are immunotherapies and experimental gene therapies.

The authorized items and the respective companies responsible are:

• PPD do Brasil Suporte a Pesquisa Clínica Ltda. — substances mRNA-4157 (V940) and Barzolvolimab
• Produtos Roche Químicos e Farmacêuticos S.A. — substance RO7790121
• GlaxoSmithKline Brasil Ltda. — Belantamab (GSK2857914)
• Merck S/A — substances M5049 and MSC2584939A
• CTI Clinical Brasil Serviços de Pesquisas Clínicas — Siplizumab (TCD601)
• Pfizer Brasil Ltda. — substances PF-08634404 (SSGJ-707) and Ponsegromab (PF-06946860)
• IQVIA RDS Brasil Ltda. — compounds HQP1351 and Daraxonrasibe (RMC-6236)
• Laboratórios Servier do Brasil Ltda. — Ivosidenib (AG-120)

Understanding Technical Terms
For consumers and patients following the development of new therapies, the terminology used by the agency may seem complex. The term “clinical trials” (tests on humans) refers to the critical step in ensuring that a new drug is safe and effective before it reaches pharmacies.

When the document mentions “approval pending” for the Drug Clinical Development Dossier (authorization for the drug’s development plan), it means that the agency has given the green light to the study protocol submitted by the company. A substantial amendment to the clinical protocol (a significant change to the research plan), on the other hand, occurs when the pharmaceutical company needs to modify an important rule or procedure while the study is underway.

The approval of these petitions (formal requests submitted by companies) is a mandatory bureaucratic step. Without the approval of the specific Anvisa coordination unit, no research involving human subjects can legally proceed in Brazil.

The Role of Oversight
Strict oversight of these processes ensures that research participants are protected by international bioethics protocols. The agency assesses whether the risks of the investigational drug are acceptable in light of the potential therapeutic benefits.

In the case of modifications to the product under investigation (changes to the formula or manufacturing process of the test drug), the agency verifies that the change does not affect the stability of the substance or patient safety. Monitoring is ongoing, and any irregularity can lead to the immediate suspension of the trials.

Next Steps in the Research
With publication in the Federal Official Gazette, the listed companies may implement the approved changes or begin new phases of data collection. It is important to note that approval for trials does not mean the drug is already available for sale.

After completing all phases of clinical research (which can take years), companies must still apply for final health registration. Only after this new phase of technical review by Anvisa can the product be sold in Brazilian hospitals or pharmacies.

The O TEMPO team automatically generated this report using artificial intelligence, based on official data. The content underwent a preliminary verification process prior to publication.