[Notice - March 6, 2026]

Dear researchers,

In the last 24 hours, instabilities were identified on the ReBEC platform in some operations in the registration form.

Our Information Technology team has already carried out the necessary adjustments.

There was no leak, loss, or alteration of the stored data.

We appreciate your understanding.

Sincerely,
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).

03/05/2026  |  European Medicine Agency

https://www.ema.europa.eu/en/news/new-guidance-conduct-clinical-trials-during-public-health-emergencies-eu 

Recommendations to streamline authorisation of new clinical trials and changes to ongoing trials to generate clinical evidence

The Accelerating Clinical Trials in the EU (ACT EU) initiative has published a draft guidance document outlining how clinical trials should be conducted during public health emergencies (PHEs). The guidance, now open for stakeholder consultation, is intended for sponsors and all parties involved in the design and conduct of clinical trials in the EU.

This is the first guidance on PHEs to reflect the EU’s current legislative framework as well as the guidelines from the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) developed following the COVID‑19 pandemic. It recommends a harmonised approach to ensure that clinical trials can be initiated, adapted and continued efficiently and safely when public health emergencies arise.

The guidance proposes regulatory mechanisms aiming to accelerate the authorisation of new clinical trials and the approval of modifications to ongoing trials during a PHE. Sponsors are encouraged to seek scientific advice from EMA’s Emergency Task Force (ETF) to ensure trials are well designed, efficient and capable of delivering meaningful data for regulatory assessment.

The draft also provides guidance for situations in which trial participants can be transferred across investigational sites. Adapted procedures or alternative approaches may be required due to the specific challenges posed by public health emergencies. The rights, safety and well-being of trial participants and the generation of scientifically…

03/04/2026  |  University College London  |  Science Daily

https://www.sciencedaily.com/releases/2026/03/260304184215.htm 

An experimental therapy for children with a severe and difficult to treat form of epilepsy appears to be both safe and highly effective at reducing seizures, according to results from an international clinical trial led by UCL (University College London) and Great Ormond Street Hospital. The findings suggest the treatment could significantly improve the health and daily lives of affected children.

The study, published in The New England Journal of Medicine, found that children with Dravet syndrome experienced seizure reductions of up to 91 percent while regularly receiving an investigational drug called zorevunersen.

Researchers also reported early evidence that the therapy may help ease some of the disorder's effects on thinking and behavior. Over a three year period, children participating in the study showed improvements in quality of life, and most reported side effects were mild.

Understanding Dravet Syndrome

Dravet syndrome is a rare and severe genetic epilepsy that causes frequent seizures that are often difficult to control. The condition is also linked to long term neurodevelopmental challenges, feeding problems, movement difficulties, and a higher risk of premature death.

For many families, treatment options remain limited. Existing medications fail to fully control seizures in many patients, and no currently approved therapies directly address the cognitive and behavioral complications associated with the disorder.

How the Drug Targets the Underlying Genetic Cause

Zorevunersen (produced by Stoke Therapeutics in collaboration with Biogen) is designed to address the root cause of Dravet syndrome by acting on a faulty gene.

Most…

03/04/2026  |   Ann & Robert H. Lurie   |  Medical Xpress

https://medicalxpress.com/news/2026-03-gene-clinical-trials-epilepsy-results.html

A Phase I/IIa clinical trials co-led by Linda Laux, MD, from Ann & Robert H. Lurie Children's Hospital of Chicago, show that the first gene regulation treatment for epilepsy is safe and well tolerated by patients with Dravet syndrome for whom antiseizure medications are not effective.

Results, published in the New England Journal of Medicine, include significant seizure reduction and improvement in other symptoms of Dravet syndrome, such as language, motor, and behavior issues. Researchers also report sustained treatment benefits in ongoing open-label extension studies.

"Our results are highly promising, especially since currently there are no approved treatments that address the underlying cause of Dravet syndrome," said Dr. Laux, Head of the Epilepsy Center and Associate Division Head of Neurology at Lurie Children's, as well as Associate Professor of Pediatrics at Northwestern University Feinberg School of Medicine.

"Since this gene regulation product targets the actual root cause of Dravet syndrome, we observed improvements in other developmental and cognitive symptoms, in addition to seizure control. This is unprecedented."

Understanding Dravet syndrome and its cause
Dravet syndrome includes a spectrum of symptoms that emerge in infancy and evolve. Most patients experience cognitive deficits, communication and behavioral impairments, motor dysfunction, growth delays, and autistic traits. Difficulties with feeding, poor appetite, and weight loss are also common.

As Dr. Laux explained, patients with Dravet syndrome have a mutation on one SCN1A (sodium channel receptor) gene with one normal SCN1A gene.…

03/04/2026 | Novo Nordisk in Valor Econômico

https://valor.globo.com/google/amp/conteudo-de-marca/novo-nordisk/noticia/2026/03/04/seguranca-juridica-pode-destravar-o-potencial-de-inovacao-em-saude-no-brasil.ghtml 

According to the pharmaceutical company Novo Nordisk, having stable rules is the way to reduce risk, attract investment, and accelerate the arrival of innovative therapies.

Even with high potential for innovation in healthcare, combining a large-scale public system, a robust private sector, and a qualified scientific community, Brazil still ranks 52nd among the 139 most innovative economies in the world in the Global Innovation Index (GII) of the World Intellectual Property Organization (WIPO). Structural challenges, such as a lack of legal predictability and bottlenecks in intellectual property, are among the major barriers hindering long-term investment decisions here.

“The development of an innovative drug takes, on average, more than a decade and involves large investments, with a high failure rate,” points out Leonardo Bia, vice president of corporate affairs and sustainability at the pharmaceutical company Novo Nordisk. Given this scenario, when there is no legal certainty and the environment is unpredictable, the perceived risk increases and ends up discouraging the viability of projects, affecting the entire chain—from research, production, and technology to qualified jobs, the executive assesses.

In the context of developing innovative drugs, a patent is the instrument that guarantees the right to protection in exchange for the risk assumed during R&D work. "However, the Brazilian patent system poses significant challenges for innovators, such as the historically long patent evaluation…

03/03/2026 | Lisa Henderson | Informa Life Sciences/Bio Xconomy

https://www.bioxconomy.com/partnering/china-biotech-continues-its-growth-trajectory 

Yao Zhong, vice president general manager for ICON China Mainland and Hong Kong, discusses latest survey results on the Chinese biotech market.

Released late last year, ICON Biotech’s 2025 China biotech sector survey report offers insights into the country’s innovation, which has received even more attention over the past two years. According to the report, therapeutic innovation coming from China is eclipsing that of the US. Since ICON Biotech first conducted a global survey of biotech in 2023, China has overtaken the US in the number of clinical trials. 

Funding optimism

While eyes for innovation are on China, its funding sources are reported by respondents as follows: partnerships with large pharmaceutical organizations (59%), venture capital firms (49%), and government grants or public funding (36%). 

Also noted in the report was the overseas out-licensing of 93 Chinese products in the first eight months of 2025. 

Zhong noted that business confidence is based on a variety of factors including Government support through policies like the 14th Five-Year Plan for National Economic and Social Development, and the October 28, 2025, release of the 15th Five-Year Plan for National Economic and Social Development, both of which target biotechnology development. 

Zhong also pointed to the large unmet medical needs and population size in China, noting that companies with advanced technology platforms feel more confident. He said, “If one biotech company owns their advanced technology platform, definitely this gives them more confidence to attract investors’ interest to them.”