[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).

04/30/2026  |   Nick Paul Taylor  |  Regulatory Affairs Professional Society

https://www.raps.org/resource/euro-roundup-uk-clinical-trial-reforms-take-effect-in-biggest-regulatory-shift-in-20-years.html 

New clinical trial regulations came into force in the UK this week, marking the biggest change in the law on running human studies in the country in more than 20 years.

The reforms introduce notifiable trials, offering an accelerated route for starting lower-risk studies. Trials that meet the notifiable study criteria will receive automatic authorization from the licensing authority, although sponsors will still need a favorable ethics committee opinion before enrolling patients. The UK has also established a notification process for some modifications to existing studies.

Other changes are intended to reduce the administrative burdens associated with safety reporting. The reforms end the need for sponsors to report suspected unexpected serious adverse reactions directly to investigators and ethics committees. Sponsors now have seven days, rather than three days, to notify the Medicines and Healthcare products Regulatory Agency (MHRA) in writing about urgent safety measures.

“These reforms to clinical trial regulations are a boost both for patients and industry investment in R&D in this country,” MHRA Chief Executive Lawrence Tallon said. “They will help to make the UK a more attractive, internationally competitive destination for both commercial and non-commercial clinical research.”

Draft guidelines published by MHRA ahead of the implementation date took effect alongside the new regulations. On the day the regulations took effect, the agency shared new guidance on formulating responses to good clinical practice (GCP) inspection findings,…

04/30/2026  |   Adam Crown  |  Databricks

https://www.databricks.com/blog/clinical-trials-run-longer-they-have-thats-patient-problem 

Industry Outcomes: Clinical trial timelines have enormous commercial implications. Most of the data that explains performance delays exists, it just isn't surfaced fast enough to act on.

Clinical trials are among the most resource-intensive and time-sensitive processes in any industry. The average Phase III trial now takes several years to complete. Each month of timeline extension represents significant cost, and more importantly, delayed access to a treatment for the patients who need it.

And yet, clinical operations functions frequently operate with a 2-4 week lag in their visibility into site-level performance issues. Enrollment velocity data arrives on a monthly cycle. Protocol deviation rates are reviewed in quarterly site assessments. By the time a performance problem at a site is identified, diagnosed, and addressed, weeks of additional timeline impact have already accumulated.

The Site Performance Visibility Problem
A VP of Clinical Operations managing a global multi-site trial cannot personally review site performance at the granularity that early intervention requires. The clinical data management systems contain the relevant data: enrollment records, protocol deviations, query response times, data entry completeness rates. What's missing is the ability to interrogate that data with the speed and specificity that operational management demands.

Genie for Clinical Trial Intelligence
Databricks Genie enables clinical operations leaders to interrogate their full trial data environment in natural language. A VP of Clinical Operations can ask: 'Which sites in the Phase II oncology trial…

04/30/2026  |  Abigail Beaney  |  Clinical Trials Arena

https://www.clinicaltrialsarena.com/news/uk-trial-reforms-come-into-effect-but-scepticism-remains/ 

The reforms to the UK clinical trial regulation came into effect on 28 April 2026, but some experts still have reservations over the impact.

The UK clinical trial regulation reforms should help make the region more attractive for clinical development, but proper adoption will be vital, experts say.

On 28 April, the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority’s (HRA’s) reforms to clinical trials came into effect, the first major change in 20 years.

These developments, which were passed in parliament, include faster assessment of first-in-human trials and the introduction of notifiable trials, a fast-track route to allow lower-risk trials to start sooner, and modifications to be approved more quickly, while maintaining the highest safety standards.  

The reforms will make it simpler to start lower-risk studies, strengthen support for early-stage research and embrace new approaches, including the use of early safety data from overseas studies that meet UK standards and computer model simulations, which can help to predict how new medicines may behave before they are tested in patients.  

While these reforms will make the UK a more attractive place to run clinical trials, experts question whether the regulation on its own is significant enough.

Industry will watch closely
Peter Rudd-Clarke, partner at law firm Osborne Clarke, said: “The UK’s new clinical trials regime is a direct response to concerns that the UK has been losing ground as a destination for research, particularly post-Brexit. By streamlining…

04/29/2026 | Federal Prosecutor's Office in Amazonas/MPF

https://www.mpf.mp.br/o-mpf/unidades/pr-am/noticias/mpf-move-acao-por-irregularidades-em-ensaio-clinico-no-amazonas-durante-pandemia-de-covid-19 

Tests on patients allegedly resulted in approximately 200 deaths in 2021;

Brazilian Federal Prosecutor's Office (MPF) has filed a civil lawsuit against the Brazilian government, a hospital, and two doctors seeking to hold those involved accountable for conducting a clinical trial of the drug proxalutamide on COVID-19 patients in Amazonas in 2021. According to the lawsuit, the study was conducted in violation of ethical, scientific, and regulatory standards. Furthermore, the MPF alleges that the experiment may have contributed to the deaths of approximately 200 participants.

According to the agency, in addition to the hospitals in the network involved, the study was also carried out in other health units in Amazonas without the necessary authorization for the state's hospital context and with alterations to the originally approved protocol. The MPF points out that the protocol authorized by the National Research Ethics Committee (Conep) stipulated that the study would be conducted only at an outpatient clinic in Brasília (DF).

However, the research was allegedly expanded, increasing the number of participants and including critically ill patients, including those on mechanical ventilation. The Federal Public Prosecutor's Office (MPF) also reports flaws in the participant consent process and omissions or delays in communicating serious adverse events to the competent authorities.

Therefore, the MPF requests that those involved be ordered to pay R$ 85 million in damages for individual and collective harm, in addition to…

04/30/2026 | Medicina S/A

https://medicinasa.com.br/evento-cientifico-fundmed/ 

Eight leading national researchers will meet on May 11th in Porto Alegre to discuss advances in clinical research and its impact on public health. The event is promoted by the Medical Foundation of Rio Grande do Sul (FundMed) in celebration of its 35th anniversary and will take place in the Auditorium of the Hospital de Clínicas de Porto Alegre (HCPA), starting at 1:30 PM, with free in-person admission and live streaming on YouTube.

The program includes six lectures and a roundtable discussion on topics such as cell therapy, new antibodies for oncology, mental health, advanced therapies in rheumatology, rare diseases, and biomarkers in Alzheimer's. Among the speakers are professors Roberto Giugliani, Eduardo Zimmer, Flávio Kapczinski, Lucia Silla, Cristina Bonorino, and Ricardo Xavier, all affiliated with research institutions in Rio Grande do Sul.

“Bringing the most qualified clinical research in the country to the public has been part of FundMed's mission for 35 years: to help transform science into real impact on people's lives,” says Professor Ricardo Machado Xavier, president of FundMed.

Founded in 1991, FundMed supports research, teaching, and innovation projects in health throughout Brazil. The institution manages the administrative aspects of more than 1,600 clinical studies and research projects, which have already generated a direct impact on the treatment of diseases and the training of researchers.

Service
Scientific Event — 35 Years of FundMed
Date: May 11th, from 1:30 PM to 4:40 PM
Location: José Baldi Auditorium – Block A of the Hospital de Clínicas de Porto Alegre (Rua Ramiro Barcelos, 2350) with live streaming on YouTube
Admission: Free, with certificate of participation Read more... Read less... Open