[Notice - March 19, 2026]

NOTICE OF SCHEDULED MAINTENANCE – ReBEC

Please be advised that the ReBEC system will undergo a scheduled maintenance outage, beginning at 6:00 p.m. on March 20, 2026 (Friday) and expected to end at 6:00 p.m. on March 22, 2026 (Sunday).

During this period, the system will be unavailable for access and for performing any operations. This measure is necessary to implement improvements and updates aimed at ensuring greater stability, security, and performance of the platform.

We recommend that users plan ahead to avoid any potential disruptions to their activities.

Thank you for your understanding.
ReBEC Coordination

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).

04/01/2026  |  The Policy Edge

https://www.policyedge.in/p/the-indo-australian-biotech-bridge-strategic-synergies-in-clinical-trials 

The Australian Trade and Investment Commission (Austrade) has highlighted a burgeoning strategic partnership at BioAsia 2026, driven by India’s AUD 236 billion biotech sector seeking Australia’s regulatory speed.

Indian innovators are increasingly utilising Australia’s Clinical Trial Notification (CTN) pathway, which allows trials to commence immediately after ethics approval, often within 6 to 12 weeks, compared to traditional 16-week timelines elsewhere. This "Fast-Track" access is coupled with a high degree of Data Governance; Australian Phase 1 data is widely accepted by the US FDA and European EMA.

While Australia provides rapid, high-quality early-phase data and significant R&D tax benefits, India offers the late-phase scale, massive patient populations, and cost-effective manufacturing necessary for global commercialisation.

Strategic Components of the Biotech Corridor

• Regulatory Efficiency: Australia’s risk-based CTN system offers a competitive advantage for firms racing for "first-in-human" or "proof-of-concept" data.
• Global Market Entry: Australian trial results act as a validated gateway for Indian firms targeting high-value markets in Boston, Paris, and beyond.
• Complementary Strengths: The partnership creates a "Practical Pathway" where Australia handles early-phase precision and India manages development volume and mass production.
• Manufacturing Synergy: Australian biotech firms are simultaneously looking to India to leverage its immense manufacturing capacity to bring Australian discoveries to the global market.
…

04/01/2026  |  IAVI ( International AIDS Vaccine Initiative)

https://www.iavi.org/features/iavi-announces-first-in-humans-clinical-trial-of-hiv-antibodies/ 

The trial, run by the HIV Vaccines Trial Network (HVTN) and HIV Prevention Trials Network (HPTN), will evaluate the safety, dosing, pharmacokinetics, and ability of four bnAbs to neutralize HIV

IAVI is pleased to announce the use of its broadly neutralizing antibody (bnAb), ePGT121v1-LS, in a first-in-human, Phase 1 clinical trial that began on March 19, 2026. IAVI’s HIV bnAbs program is designed to develop efficacious antibodies that can prevent HIV transmission. The program is specifically geared for eventual use to prevent HIV transmission to infants during the post-natal period. With 120,000 children newly acquiring HIV in 2024 alone, and 50 percent of infant HIV acquisition taking place in the breastfeeding period, there is a clear need for additional prevention tools developed to protect this vulnerable population. The onset of this clinical trial is a significant step in examining whether a combination of broadly neutralizing antibodies could be this new tool.  With robust safety and dose data collected through this study, which has only adult participants, IAVI’s team will have the necessary data to plan future studies in infants.

This clinical trial, HVTN 141/HPTN105, will use four antibodies that target different HIV receptors. Based on past studies, the antibodies together are expected to neutralize more strains of HIV than any antibody alone. IAVI’s antibody will be given by itself and together with two of the three additional antibodies, VRC07-523LS and PGDM1400LS. The fourth antibody, PGT121.414.LS, will be given by itself and in combination with these same two antibodies. Doses will be delivered by IV, under…

03/30/2026 | Raphael Bezerra | Jornal Opção

https://www.jornalopcao.com.br/ultimas-noticias/estudo-brasileiro-aponta-melhora-na-memoria-em-pacientes-com-alzheimer-tratados-com-cannabis-808878/ 

A group of 13 Brazilian researchers led by Francisney Pinto Nascimento, PhD in pharmacology at the Federal University of Latin American Integration (Unila), identified cognitive improvement in Alzheimer’s patients treated with low-dose cannabis extracts. The results appear in two scientific publications—a 2022 report and a randomized clinical trial published in 2025—which point to positive effects on memory, with a safety profile considered favorable.

The research line investigates the use of cannabinoids as a therapeutic alternative for improving Alzheimer’s, a neurodegenerative condition that affects millions of people worldwide and for which there is still no cure. For biomedical scientist and researcher Isabela Carvalho Freitas, affiliated with the Federal University of Goiás (UFG), the observed effects can be explained by the interaction of cannabinoids with the endocannabinoid system, which is responsible for regulating functions such as mood, sleep, appetite, and stress response.

According to the expert, modulating this system may contribute to symptom management and improved quality of life in Alzheimer’s patients, particularly regarding behavioral symptoms, which still pose significant clinical challenges.

She also highlights the growing academic interest in the topic and notes that historical regulatory barriers have hindered the production of robust scientific evidence. “The lack of research restricts use, and the restriction hinders the advancement of research,” she states in an interview with Jornal…

03/30/2026  |  Maria Prevot and Franco Mauro Russo Brugioni  |  Migalhas.com

 https://www.migalhas.com.br/depeso/452905/o-direito-a-saude-entre-a-inovacao-e-a-regulacao-da-polilaminina 

Polylaminin, in initial trials, sparks legal debate over coverage of experimental treatments in the face of urgency and scientific uncertainty.

Reports have recently surfaced regarding a new substance, still in the testing phase, that could be used in an attempt to reverse paralysis resulting from spinal cord injury.

This substance is polylaminin, a derivative of laminin, developed through research at the Federal University of Rio de Janeiro (UFRJ) and currently funded for clinical trials. The development of this substance brings a topic in Health Law back to the center of the debate: when therapeutic hope gives rise to legal obligations for coverage before scientific consolidation. The case is emblematic because the news highlights that this is investigational technology, in the early stages of human testing, aimed at severe acute spinal cord injuries.

From a regulatory standpoint, the turning point is the transition from the experimental phase to authorized clinical research. In January 2026, Anvisa authorized a Phase 1 study to evaluate the safety of polylaminin in five patients with complete thoracic injuries. The Ministry of Health has signaled institutional interest in innovative technologies for the SUS. These developments do not imply automatic registration or incorporation, but they raise the level of seriousness of the treatment in the eyes of the judiciary, as they indicate risk management and monitoring of adverse events.

In this interim period—between research authorization and incorporation—the likelihood of judicial rulings increases. There is a concrete…

03/30/2026 | Bio-Manguinhos

https://campusvirtual.fiocruz.br/portal/?q=noticia/97937 

The Institute of Immunological Technology (Bio-Manguinhos/Fiocruz) promotes this second fair, March 30, at 2 p.m., in the first edition of WebRede: Effectiveness and safety of the vaccine against Covid-19 in health professionals and messenger RNA technology. The activity is carried out in partnership with the Fiocruz Clinical Research Network and kicks off a series of webinars scheduled for this year.

The event, promoted by the Department of Medical Affairs, Clinical Studies and Post-Registration Surveillance and the Desk of Technological Development Projects, will present the Rede de Estudos Observacionais (Covid-19 Network) and the results of Eixo 2 of the study, which supports the effectiveness and safety of Covid-19 vaccines, with focus Vaccines distributed by the National Immunization Program in health professionals, along with messenger RNA technology. You will have participated in the Bio-Manguinhos Technological Development Projects Desk and at the University Hospital of Brasília (HUB-UnB/Ebserh).

The webinar is intended for health professionals, researchers, postgraduates, managers, research participants and others interested in the subject. Registrations must be made on the Even3 platform. You will have transmission via Teams, with access to the Even 3 platform.