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 and Traditional Communities – Clinical research and observational studies specifically designed for or preferably addressing traditional communities (quilombolas, caiçaras, faxinalenses, among others) and indigenous peoples, both within and outside legally demarcated territories, observing the specific regulations for each case.

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.

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).

10/17/2025  |   Kerry Cullinan  |  Health Policy Watch

https://healthpolicy-watch.news/pregnant-and-breastfeeding-women-and-children-in-clinical-trials/ 

The first pregnant woman with malaria was enrolled in a clinical trial in Mali to compare three different malaria treatment regimens earlier this month – a historic event as pregnant and breastfeeding women and babies are seldom included in clinical trials despite being more vulnerable to several illnesses.

But there is growing momentum for including “under-represented groups” in clinical trials to ensure that medicines developed are suitable for all those who need them most.

Malaria in pregnancy is responsible for around 20% of stillbirths and 11% of all newborn deaths in sub‑Saharan Africa, as well as some 10,000 maternal deaths globally each year. It can also cause severe maternal anaemia, miscarriage, stillbirth, preterm delivery and low birthweight. 

Back in 1998, the World Health Organization (WHO) recommended artemisinin-based combination therapy (ACT) as the standard of care for malaria – but it only updated its guidelines for malaria to include pregnant women in their first trimester in 2022, according to Dr Myriam El Gaaloul, head of clinical and regulatory sciences at Medicines for Malaria Venture.

“With the threat of emerging resistance to malaria drugs, alternatives are needed, and I think we all agree that we cannot afford to wait for another quarter of century [for treatment for pregnant women],” El Gaaloul told a webinar on under-represented populations in clinical trials, hosted by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) as part of its African Regulatory Conference.  

The trial, which will also run in Kenya and Burkina Faso,…

10/13/2025 | Camila Neumam | Butantan Institute

https://butantan.gov.br/noticias/pesquisa-do-butantan-define-nova-nomenclatura-de-linhagens-do-virus-da-dengue-para-otimizar-vigilancia-genomica 

A study conducted in partnership with 23 other institutions, including Yale University in the US, expands classification beyond genotypes, demonstrating continuous mutations of the virus

A study conducted by researchers at the Center for Viral Surveillance and Serological Evaluation (CeVIVAS) at the Butantan Institute, in conjunction with 23 other institutions, including Yale University in the United States, defines a new nomenclature system for dengue virus (DENV) strains to complement genotype classification. 

The goal is to facilitate genomic surveillance, that is, to promote communication between laboratories and health authorities, making strain tracking more accurate and comparable, in addition to monitoring potential strains with epidemiological or clinical relevance. 

The research, entitled A new lineage nomenclature to aid genomic surveillance of dengue virus, was published in the scientific journal PLOS Biology.

Bioinformaticians Alex Ranieri and James Siqueira, from CeVIVAS, developed, in conjunction with 23 institutions, a new nomenclature system for dengue virus lineages.

"From an epidemiological point of view, the dengue that circulates is the same as it has been for the last 20 years, and it seems that the virus is not changing, when in fact it is. The new nomenclature classifies the virus systematically, making it easier to identify and allowing any researcher to classify these samples," says Alex Ranieri, a bioinformatician at CeVIVAS and the Butantan Cell Cycle Laboratory (LCC) and one of the study's lead…

10/14/2025 | Laura Cordeiro | IOC/FIOCRUZ

https://agencia.fiocruz.br/novo-laboratorio-de-alta-contencao-nivel-3-amplia-capacidade-de-pesquisa-nacional 

Last Friday (10/10), Fiocruz inaugurated another high-containment laboratory for research with biomodels, classified as biosafety level 3 (NBA3). The new facility represents a strategic advance for Brazilian science, expanding the country's capacity to conduct studies on infectious agents relevant to public health. It is the first facility of its kind at the Oswaldo Cruz Institute (IOC/Fiocruz) – and one of the few in Brazil.

Fiocruz recently inaugurated an NBA3 facility in Recife, at Fiocruz Pernambuco. IOC/Fiocruz already had two conventional NB3 laboratories, focused on in vitro experiments, in which it is a reference. Unlike these units, the new space follows even stricter protocols, as it allows in vivo studies on the interaction between pathogens and their hosts. This approach is essential for health surveillance and vaccine development.

Vice President of Research and Biological Collections at Fiocruz, Alda Maria Cruz pointed out that the Covid-19 pandemic has left important legacies and driven scientific advances. “Biomodel studies are fundamental to public health; they are a kind of master key to discoveries,” she said.

The coordinator of the Animal Experimentation Center (CEA) at IOC/Fiocruz, André Nunes de Sales, highlighted the impact of the new structure. “This new laboratory is capable of promoting high biological containment and reducing occupational risks. Now, we can handle pathogens that were not possible before. For the population, this means faster responses to health emergencies,” he said.

With 70 m², the space has an advanced technological structure, consisting of four main areas,…

10/14/2025 | Mayo Clinic released by NewsWise

https://www.newswise.com/articles/ensaios-cl-nicos-virtuais-podem-prever-o-sucesso-de-medicamentos-para-insufici-ncia-card-aca 

Mayo Clinic researchers have developed a new way to predict whether existing drugs could be repurposed to treat heart failure, one of the world's most pressing health challenges. By combining advanced computer modeling with real-world patient data, the team has created “virtual clinical trials” that could facilitate the discovery of effective therapies while reducing the time, cost, and risk of unsuccessful studies.

“We have demonstrated that with our framework, we can predict the clinical effect of a drug without the need for a randomized controlled clinical trial. We can say with a high degree of confidence whether a drug is likely to be successful or not,” says Ph.D. Nansu Zong, a biomedical informatics specialist at Mayo Clinic and lead author of the study published in npj Digital Medicine.

An urgent need
Heart failure affects more than 6 million Americans and is the leading cause of hospitalization and death. Despite decades of research, treatment options remain limited, and many clinical trials are unsuccessful. Traditional drug development is expensive and time-consuming, often taking more than a decade and costing about $1 billion to bring a single therapy to market.

Drug repurposing—finding new uses for drugs already approved for other conditions—may offer a faster and less costly path. Because the safety of these drugs is already established, researchers can move directly to studying their potential benefits in new diseases. However, determining which drugs are worth investigating remains a major challenge.

Dr. Zong led the efforts of a…

10/14/2025 | Saúde Digital News

https://saudedigitalnews.com.br/14/10/2025/novo-decreto-federal-moderniza-a-regulacao-de-pesquisas-clinicas-e-impulsiona-a-inovacao-no-setor-de-saude/ 

With the aim of bringing Brazil closer to international clinical research models, Federal Decree No. 12,651/2025, which regulates Law No. 14,874/2024, establishes guidelines for research involving human subjects, formalizing the National System of Ethics in Research Involving Human Subjects (SINEP) and establishing faster regulatory deadlines and procedures, facilitating access to health innovations and reducing bureaucratic obstacles, while ensuring ethical and regulatory protection for participants

The law firm Fialdini Einsfeld Advogados analyzes the impacts of recent alignments for innovation in the health sector, especially in the context of clinical research and the use of new technologies, highlighting the reduction in review times by Research Ethics Committees (CEPs) from 180 days to up to 30 days, the evaluation period by the National Health Surveillance Agency (Anvisa) of up to 90 business days, the guarantee of therapeutic continuity (for up to 5 years) for research participants who show proven benefit, in situations of serious diseases with no therapeutic alternative, and stricter and more transparent rules for free and informed consent, vulnerable groups, and the responsibilities of researchers and sponsors.

"Since the law was passed, we have observed that many pharmaceutical companies, after years of not including Brazil in global clinical research, have returned to considering the country as a location for conducting studies that could revolutionize medicine. This resumption is likely to gain momentum with the issuance of the decree and directly benefits thousands…