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:

ReBEC support is provided exclusively by official online channels.

Service channels:
* IA ReBEC@ (virtual assistant): automated service 24 hours a day, 7 days a week
* Humanized chat: from Monday to Friday, from 8 a.m. to 12 p.m. (Brasília time)
* Institutional WhatsApp / Dedicated line: +55 21 97203-4750
Service from Monday to Friday, from 9 a.m. to 4 p.m. (Brasília time)

Priority and/or urgent administrative demands outside the file schedule may be submitted to: plantao.rebec@gmail.com

We recommend that all requests be accompanied by a login, linked email or study registration number. (RBR-xxxxxxx), when applicable, for agility in attention.

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).

06/30/2026  |  Andrea Vialli  |  Valor Econômico

https://valor.globo.com/google/amp/publicacoes/especiais/revista-saude/noticia/2026/06/30/novos-marcos-regulatorios-impulsionam-a-pesquisa-clinica-no-brasil-e-abrem-caminho-para-tratamentos-promissores.ghtml

Recent regulatory advances are creating an environment conducive to testing new drugs and therapies and getting them to patients more quickly

Recent regulatory advances, such as the new legal frameworks established by Law No. 14,874/2024 for clinical research and by Law No. 15,385/2026, for the development and incorporation of cancer-fighting technologies into the Unified Health System (SUS), are creating an environment conducive to testing new drugs and therapies and getting them to patients more quickly. Today, Brazil accounts for less than 2% of global clinical research, but the new regulations aim to narrow this gap, foster domestic biotechnology, and attract more international research. According to experts, the country possesses key attributes to expand its relevance in clinical research, including centers of excellence, qualified professionals, and a population with diverse physical and ethnic characteristics. “For the global pharmaceutical industry, this opens the door to treating the country not as a distant stop along the way, but as a market that can be integrated into expansion plans,” says Fernanda Manhães, director of regulatory services at ClarkeModet Brasil, a consulting firm specializing in innovation and intellectual property.

The favorable regulatory climate is driving increased investment from both domestic and multinational companies. AbbVie, a spin-off of Abbott, reported a 35% increase…

06/30/2026  |  Siddhi Mahatole  |  CNBC AFRICA via Reuters

https://www.cnbcafrica.com/2026/africa-cdc-seeks-18-million-in-urgent-support-for-ebola-drug-trials-in-drc 

The Africa Centres for Disease Control and Prevention on Tuesday called for $18 million in urgent funding to support trials of experimental Ebola treatments in the Democratic Republic of Congo, warning that delays could jeopardize efforts to contain the outbreak.

The appeal comes as clinical trials evaluating potential therapies are due to begin this week in Bunia, capital of Ituri province, where the first cases involving the Bundibugyo strain of Ebola were confirmed.

The program is testing Gilead Sciences’ GILD.O oral drug obeldesivir to prevent infection in people exposed to the virus, and remdesivir and Mapp Biopharmaceuticals’ antibody to reduce mortality among infected patients, the Africa CDC said.

The program also includes accelerated development and manufacturing of next-generation Bundibugyo-specific vaccines, the agency added.

Africa CDC said funding for vaccine-related studies was largely in place, but therapeutic trials remained underfunded.

“We have the science. We now need the funding to use it. Clinical trials must start this week, and every day of delay costs lives we could save,” said Dr. Jean Kaseya, director general of Africa CDC.

The agency called on governments, development banks, philanthropic organizations and other partners to provide $16 million within days to continue the obeldesivir study and an additional $2 million to $3 million for contact tracing.

Africa is working with partners such as the World Health Organization, the International AIDS Vaccine Initiative and the Coalition for Epidemic Preparedness Innovations to assemble “one of…

06/30/2026  |  Gareth Macdonald  |  BioXconomy

https://www.bioxconomy.com/clinical-and-research/china-updates-clinical-trial-rules-on-data-ethics 

The revisions stress data transparency and participant privacy protection.

Revised Good Clinical Practice (GCP) regulations that come into force in China in September introduce new rules on data governance and emphasize the importance of compliance with international ethical principles.

China’s National Medical Products Administration published the document (Mandarin) on June 8, explaining the aim was to “optimize the quality management of drug clinical trials” and cultivate a standardized and efficient research ecosystem.

The guideline—which is the first update since 2020—consists of sections covering a range of trial-related topics, from rules for principal investigators and institutions involved in studies through to drug industry sponsors.

Clinical trial data governance is covered in a new section, which stresses that information from studies should be stored in a transparent manner. It also underlines the importance of ensuring the privacy of study participants.

“All paper and electronic materials related to clinical trials should be properly recorded, processed, and stored to ensure the reliability and traceability of the data. The privacy and personal information of trial participants should be protected, in accordance with the relevant requirements of our country's personal information protection laws.

“The systems and processes used for data collection, management, and analysis should meet the intended purposes and be commensurate with the risks to trial participants and the importance of the collected data” the NMPA writes.*

The revision also reminds…

06/30/2026  |  Clínic Barcelona

https://www.clinicbarcelona.org/en/news/an-international-consensus-article-establishes-clinical-trial-design-in-liver-cancer 

Researchers from the Cancer Area at IDIBAPS and the Clínic Barcelona Comprehensive Cancer Centre have led the development of an international consensus document published in Nature Reviews Clinical Oncology, one of the most prestigious journals in oncology.

The article, promoted by the four main scientific societies in liver oncology —the European Association for the Study of the Liver (EASL), the American Association for the Study of Liver Diseases (AASLD), the International Liver Cancer Association (ILCA) and the American Society of Clinical Oncology (ASCO)— provides 102 consensus recommendations to guide clinical trial design and the definition of endpoints in phase II and III experimental studies in hepatocellular carcinoma.

This initiative has been led by Dr Josep M. Llovet, Head of the Translational Research in Hepatic Oncology group at IDIBAPS, Professor of Medicine at the University of Barcelona, ICREA professor, and Professor of Medicine at the Icahn School of Medicine at Mount Sinai; with the participation of Dr Ezequiel Mauro, a member of the same group.

What is hepatocellular carcinoma?
Hepatocellular carcinoma is the most common type of liver cancer, affecting close to one million new patients annually. It typically develops in the context of chronic liver disease, such as cirrhosis or viral hepatitis. This coexistence of tumor and underlying liver damage makes disease progression particularly complex and has a direct impact on both prognosis and treatment options.

In recent years, treatment has evolved significantly, and nine systemic therapies…

06/29/2026  |  Kazinform International

https://qazinform.com/news/japan-prepares-first-human-trial-of-pig-kidney-transplants-457aee/amp 

A Japanese biotechnology startup is preparing the country's first clinical trial of kidney transplants from genetically modified pigs to humans, Qazinform News Agency correspondent reports.

PorMedTec announced on Monday that it has reached a basic agreement with Hokkaido University and the Tokushukai Medical Corporation to prepare a company-sponsored clinical trial of xenotransplantation, in which organs from animals are transplanted into human patients.

The trial is expected to take place at Hokkaido University Hospital in Sapporo and Shonan Kamakura General Hospital in Kanagawa Prefecture. The company plans to finalize the trial protocol in consultation with Japanese regulators, with clinical testing targeted to begin in 2028.

PorMedTec said it aims to make pig kidney transplantation a treatment option for patients with severe kidney failure once the procedure receives regulatory approval. The company also intends to establish a manufacturing and supply network capable of providing donor pig kidneys to medical institutions across Japan.

The project uses genetically modified pigs originally developed by U.S. biotechnology company eGenesis. The donor animals have undergone 69 genetic modifications designed to reduce the risk of organ rejection and eliminate the possibility of transmitting porcine endogenous retroviruses, known as PERVs.

According to the company, eGenesis has already carried out four pig-to-human kidney transplant procedures in the United States since 2024 under authorization from the U.S. Food and Drug Administration. The longest reported period without dialysis following transplantation is 271 days.

PorMedTec reproduces…