PRIORITY SERVICES

The Brazilian Registry of Clinical Trials (ReBEC) presents the new fast tracks for clinical research and observational studies on INDIGENOUS PEOPLE AND TRADITIONAL COMMUNITIES and on NEGLECTED TROPICAL DISEASES (NTDs). Fast-track can reduce the normal approval period for clinical trials to less than 48 hours, if the documentation, information and any mandatory changes requested are provided by the registrant.

The already existing fast-tracks and the attendance to other studies will not be interrupted. Priority care is granted with a view to accelerating clinical research in epidemiological emergency situations and/or studies with the potential to reduce socioeconomic inequalities, keeping the perspective aligned with the forefront of ethics and transparency, diplomacy in health, scientific collaboration and diversity and specificities of recruitment and health care.

 

 

 

FAST-TRACKS IN OPERATION:

I - Indigenous Peoples, Traditional Communities, Human Migration and Refugee Movements – clinical research and observational studies dedicated to or preferably addressing traditional communities (quilombola, caiçara, faxinalense, among others), Indigenous peoples (within or outside legally demarcated territories), and refugee groups, taking into account the specificities established by regulation, on a case-by-case basis.

II - Neglected Tropical Diseases – Leprosy, Tuberculosis, Leishmaniasis, Schistosomiasis, Scabies, Chagas disease, Intestinal parasitoses, Viral hepatitis, Trachoma, Onchocerciasis, Human rabies transmitted by dogs.

III - National and International Public Health Emergencies – Mpox, Covid-19.

IV - Arboviruses – Zika, Dengue, Chikungunya, Malaria, Yellow fever.

V - WHO Prioritized Pathogens for Latin America – Studies dealing with World Health Organization prioritized pathogens for Latin America, as listed in the document "PATHOGENS PRIORITIZATION - A SCIENTIFIC FRAMEWORK FOR EPIDEMIC AND PANDEMIC RESEARCH PREPAREDNESS" (Health Emergencies Programme, 2024) – Lassa fever, Cholera, Black Death (Plague), Bacillary dysentery or Shigellosis, Salmonella, Pneumonia, Urinary tract infection, MERS-CoV, SARS, Ebola virus (EVE), Marburg virus (MVE), Ebola virus (EVE) Sudan subtype, Hantavirus pulmonary syndrome (HPS), Hemorrhagic fever with renal syndrome (HFRS), Crimean-Congo hemorrhagic fever, Influenza A H1, Influenza A H2, Influenza A H3, Avian influenza (Influenza A H5N1), Avian influenza (Influenza A H6), Avian influenza H7 (Avian influenza H7), Avian influenza H10 or Avian influenza H10, Nipah disease, Viral hemorrhagic disease, Poliomyelitis, Hand-foot-and-mouth disease, Herpangina, Viral meningitis, Smallpox, Mpox, Human Immunodeficiency Virus (HIV), Venezuelan equine encephalitis (VEE).

VI - WHO Prioritized Prototype Pathogens for Latin America – Studies dealing with World Health Organization prioritized prototype pathogens for Latin America, as listed in the document "PATHOGENS PRIORITIZATION - A SCIENTIFIC FRAMEWORK FOR EPIDEMIC AND PANDEMIC RESEARCH PREPAREDNESS" (Health Emergencies Programme, 2024) – Recombinant mastadenovirus, Mastadenovirus blackbeardi serotype 14, Mammarenavirus juninense, Mammarenavirus lujoense, Mamastrovirus virginiaense, Orthobornavirus bornaense, Orthoflavivirus encephalitidis, Orthoflavivirus nilense, Orthohepadnavirus hominoidae genotype C, Paslahepevirus balayani genotype 3, Protoparvovirus carnivoran, Orthobunyavirus oropoucheense, Phlebovirus riftense, Orthopicobirnavirus hominis, Enterovirus alphacoxsackie 71, Enterovirus deconjuncti 68, Metapneumovirus hominis, Orthopoxvirus vaccinia, Genus Vesiculovirus, Genus Rotavirus, Orthoreovirus mammalis.

VII - Studies on the impacts of climate change, the effects of scientific denialism, and health misinformation -The physical, mental, and social consequences of environmental and climate changes on human populations; The impact of extreme weather events and environmental degradation on infectious, chronic, or emerging diseases; The influence of denialist narratives and misinformation in Health on adherence to preventive measures, vaccination, treatments, and risk behaviors, as well as the physical and mental outcomes for human beings and populations.

 

INSTRUCTIONS:

We recommend reading the Registrant Handbook. Material available at LINK.

1. Register or log in and normally fill out the forms in Portuguese and English. For English, in case of difficulty, use the Google Translate tool (or another free translation tool).
2. Attach the mandatory ethics committee documentation and submit the form.
3. Register the service number on your Whatsapp. Send a message with your name and login. IT IS NOT NECESSARY NOR RECOMMENDED TO SEND YOUR PASSWORD.
4. A reviewer will respond to you. Choose the service modality: chat, audio recordings or voice call by appointment.
5. Your form will be proofread in both languages. Follow the remaining guidelines to finalize the approval.

 

 

CONTACTS:

Support is online, via chat, dedicated telephone line (see phone number below) and WhatsApp, from 9 am to 5 pm (Brasília time).

Administrative, priority and/or urgent matters outside office hours: plantao.rebec@gmail.com
Line 1: +55 21 97203-4750

 

ABOUT REBEC:

The Brazilian Registry of Clinical Trials (ReBEC) is a free access virtual platform for recording experimental and non-experimental studies carried out on human beings and conducted in Brazilian territory, by Brazilian and foreign researchers. ReBEC is a joint project of the Ministry of Health (DECIT/MS), the Pan American Health Organization (OPAS) and the Oswaldo Cruz Foundation (FIOCRUZ). ReBEC's Executive Committee is composed of the aforementioned institutions and the National Health Surveillance Agency (ANVISA).

11/28/2025 | Camila Neumam | Butantan Institute

https://butantan.gov.br/noticias/vacina-butantan-dv-marca-virada-historica-na-prevencao-da-dengue-no-brasil-e-redesenha-estrategias-de-saude-publica 

Authorities highlight that the world's first single-dose dengue vaccine will transform prevention in the country, expanding coverage, facilitating logistics, and strengthening technological autonomy.

State, federal, and international health authorities classified the approval of the Butantan-DV vaccine by the National Health Surveillance Agency (Anvisa) as a victory for Brazilian science and health sovereignty, marking a historic turning point in the fight against dengue in Brazil.

According to them, its future incorporation into the National Immunization Program (PNI) will be able to change the epidemiological scenario of the country, preventing epidemics and deaths; it should increase coverage as it is a single dose; and it will facilitate the logistics of delivery and distribution of the immunizing agent.

The approval took place this Wednesday (26) at a signing ceremony of the Commitment Term for Studies and Monitoring of the Dengue Vaccine between the Butantan Institute and Anvisa, the last step before the registration of the vaccine. The signing takes place after the conclusion of the evaluation of the immunizing agent by the agency's technical areas and confirms the approval, ensuring that the vaccine is safe and effective for Brazilians, but also defining obligations, deadlines and delivery of complementary information, which guarantees transparency and predictability to the process.

Butantan-DV was approved for people aged 12 to 60 years old, but Butantan will conduct studies with the vaccine in the elderly to expand the age range.…

11/26/2025 | Instituto Butantan

https://butantan.gov.br/noticias/vacina-da-dengue-do-instituto-butantan-primeira-do-mundo-em-dose-unica-e-aprovada-pela-anvisa 

Butantan Institute has already produced more than one million doses to make available to the Ministry of Health

The Butantan-DV dengue vaccine from the Butantan Institute, an agency linked to the São Paulo State Health Secretariat, was approved this Wednesday (November 26) by the National Health Surveillance Agency (Anvisa) for use in the Brazilian population aged 12 to 59 years. With the favorable opinion, the immunizing agent, which is the world's first single-dose dengue vaccine, should be included in the National Immunization Program (PNI). The start of vaccination and the age range for application will still be defined by the Ministry of Health.

Even before approval, the Butantan Institute had already begun producing the immunizing agent in its industrial park, having more than one million doses ready to be made available to the National Immunization Program (PNI). In addition, Butantan has entered into an international partnership with the Chinese company WuXi to increase production. The agreement will allow for an expansion of supply capacity to deliver approximately 30 million doses in the second half of 2026.

“It is a historic achievement for science and health in Brazil. A disease that has afflicted us for decades can now be faced with a very powerful weapon: the single-dose vaccine from the Butantan Institute. A development made by Brazilian scientists, workers, and volunteers that could save lives throughout the country,” says the director of the Butantan Institute, Esper Kallás.

For the Secretary of State for Health of São Paulo, Eleuses Paiva, the immunizing…

11/28/2025 | Fernando de Rezende Francisco, Norberto Prestes | JOTA

https://www.jota.info/opiniao-e-analise/artigos/lei-da-pesquisa-com-seres-humanos-pode-atrair-milhoes-de-investimentos-ao-pais 

Modernization of the regulatory framework ensures legal security and predictability for the IFA industry.

Legal certainty and predictability are the fundamental bases for the sustainable development of the pharmaceutical input industry established in the country, regardless of its capital origin.

Premises to attract investments to a sector that invests large sums in new molecules, APIs, and drugs, to foster innovation and increase access for the Brazilian population to medicines, therapies, and treatments that can save lives.

And it is precisely on this wave of legal certainty that the regulation of Law 14.874, of May 28, 2024, rides, which modernizes the Brazilian regulatory framework regarding research with human beings and establishes the National System of Ethics in Research with Human Beings, ensuring predictability, defined approval timelines, and safety for all involved, especially for research participants.

According to research conducted by the Association of Pharmaceutical Industry Research (Interfarma), in partnership with IQVIA, the Human Research Law could generate an annual boost of R$ 6.3 billion to the Brazilian economy, the creation of 56,000 qualified jobs per year, in addition to directly benefiting around 286,000 patients.

In this fertile field of consolidating a predictable regulatory environment and accelerating regulatory review timelines, the country will have the possibility to advance development phases, reducing the total cycle of new products and the costs involved in the innovation process, as…

11/26/2025 | Tatiana Branco | Medicine S/A

https://medicinasa.com.br/pesquisas-doencas-raras/ 

Recognized as conditions that affect 1 in every 2,000 individuals, these rare gifts are currently more than 7 thousand types known and impact more than 300 million people worldwide. In Brazil, around 13 million people live together with some rare goods, which corresponds to 5% of Brazilians.

This expressive number faces the country as an increasingly relevant actor in the international census of research on the topic. Along with the population dimension, government initiatives, advances in genomic science and participation in international clinical protocols consolidate Brazil as a strategic pole in the search for innovative solutions.

The creation of the National Comprehensive Care Policy for People with Rare Doenças, in 2014, marked a water divider. Since then, 17 SUS Reference Centers have been enabled, dedicated to diagnosis and treatment. The network, even though it is uneven between regions, represents progress in the direction of more structured and specialized attention. In parallel, the National Network of Rare Diseases (RARAS) launched the Brazilian Atlas Online, which already brings together almost 20 thousand clinical and epidemiological records, covering more than 2,300 diseases. These are one of the most open-ended initiatives in Latin America.

There are still two big challenges in terms of time tied to diagnostic confirmation. A recent study showed that a Brazilian patient takes, on average, 5.4 years to discover precisely what is happening — a long wait often marked by suffering. Cases such as phenylketonuria and cystic fibrosis are likely to be included in neonatal triage, which demonstrates the importance of expanding preventive policies and support networks.

The field of clinical research, or the country, stands out in multi-centre…

11/26/2025  |  Jornal Cidades  RS

https://www.jornaldocomercio.com/jornal-cidades/2025/11/1227253-ufpel-participa-da-aprovacao-da-vacina-brasileira-contra-dengue.html 

The Federal University of Pelotas (UFPel), through the Clinical Research Center of the Teaching Hospital (HE-UFPel), participated in the study that led to the approval by the Brazilian Health Regulatory Agency (Anvisa) of the Brazilian dengue vaccine developed by the Butantan Institute. The approval is a historic milestone for science and public health in the country.
The vaccine is the first in the world capable of offering protection with just one dose, which translates into greater adherence by the population, simpler campaigns to organize, faster vaccination coverage in health emergencies, and a reduction in outpatient visits, hospitalizations, and deaths related to dengue. The vaccine is expected to be incorporated into the National Immunization Program (PNI).

Although the vaccine protocol began about a decade ago, UFPel was incorporated into the last stage of the research in 2022, participating in the Batch Consistency study, a fundamental regulatory requirement for the vaccine to be approved. In the stage conducted, 335 volunteers were randomized. The data collected at the institution were analyzed for consistency between batches, safety, and efficacy of the product. Participants who received a placebo during the study were subsequently vaccinated, as provided for in the protocol.

The vaccine was studied in people aged 12 to 59. In February 2026, UFPel will begin a new phase, in partnership with the Butantan Institute, to evaluate the vaccine in elderly people over 60, considering that mortality is higher in this age group and that there is still no vaccine approved worldwide for this group. The…