Brazilian Clinical Trials Registry (ReBEC) is a World Health Organization (WHO) recognized primary registry. Registration of protocol is required to conduct any trial as per the WHO International Clinical Trials Registry Platform (ICTRP) criteria.
| Registries at a Glance | |||||
| Registry | PHUSE Categorization | Information to be Entered By | Route of Data in Registry | Study Type | Language |
| ReBEC | Mandatory National Database (includes Ethics Requirement) | Sponsor | Through a dedicated registration platform (process independent from clinical trial application) |
Interventional (Phase 1-4);Observational |
English 
Spanish 
Portuguese |
| Registration and Results Requirements | |||
| Registry | Activity | Legal Requirement | Timing |
| ReBEC | Registration |
Yes |
After approval, prior to first participant enrollment |
| Results |
No |
The final report should be submitted within 12 months of the clinical trial end date | |
Registry Updates
- November 2020: Brazil Regulatory Update - All the services including registering, approving, or editing the studies on the current platform (ReBEC) are temporarily suspended, due to the data migration process from the current platform to Brazil’s new platform ‘OpenRebec’ from 19 November 2020 to 23 November 2020. OpenRebec brings new and improved features and is fully compliant with the standards of … Continue reading "November 2020: Brazil Regulatory Update"
- April 2020: Comparing Guidances on COVID-19 Disruptions of International Clinical Trials - On April 08, 2020, Ropes & Gray published a document comparing the guidance documents related to COVID-19, its impact on and additional requirements for conducting the clinical trials. The guidance documents involved are issued by the European Medicines Agency (“EMA”), the French National Agency for Medicines and Health Products Safety (“ANSM”), the German Federal Ministry of Health … Continue reading "April 2020: Comparing Guidances on COVID-19 Disruptions of International Clinical Trials"
- July 2018: Brazil Regulatory Updates - As per ResolutionNo466 and OSNo001/2013, Brazil has a centralized registration process for ethics committee (ECs) and requires institutional level EC approval for each trial site. The National Commission for Ethics in Research (Comissão Nacional de Ética em Pesquisa) (CONEP) serves as the central body that reports to the National Health Council (NHC) (Conselho Nacional de Saúde (CNS)), the advisory body for … Continue reading "July 2018: Brazil Regulatory Updates"
References
- RESOLUTION -RDC No. 9. Clinregs. https://clinregs.niaid.nih.gov/sites/default/files/documents/brazil/ResolutionNo9-English.pdf. Published February 20, 2015. Accessed November 12, 2018.
- RESOLUTION -RDC No. 449, amends the Resolution-RDC No. 9, of February 20, 2015. b00b3d31-a0e0-41c4-a35c-7544d652779d (anvisa.gov.br). Published December 17, 2020. Accessed December 31, 2020.
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Anvisa’s Regulatory Agenda 2021-2023.Agenda 2021-2023 – Portuguese (Brazil) (www.gov.br). Published May 21, 2021. Accessed June 03, 2021.