BRAZIL Law and Practice Contributed by: Bruna Rocha, Jessica Filka, Juliana Marcondes and Victoria Cristofaro, COSRO
2. Clinical Trials 2.1 Regulation of Clinical Trials
tices, with importation handled under the rules appli- cable to research-use products. 2.2 Securing Authorisation to Undertake a Clinical Trial Clinical trial authorisation in Brazil requires two parallel clearances: • ethics approval through the CEP/CONEP system, which covers the protocol and informed consent documents and provides ongoing oversight of amendments and reportable events; and • ANVISA regulatory clearance, which varies by product type (pharmaceuticals and biologics follow clinical trial dossier submission routes with import controls, while medical devices require a device clinical investigation dossier). Before enrolling patients, sponsors must also com- plete operational prerequisites, including trial regis- tration, executed agreements with sites and vendors, appropriate insurance/indemnity coverage, General Data Protection Law ( Lei Geral de Proteção de Dados – LGPD)-compliant data governance for cross-bor- der transfers, and defined responsibilities for safety reporting and quality oversight. 2.3 Public Availability of the Conduct of a Clinical Trial The conduct of clinical trials involving pharmaceuticals and medical devices in Brazil is subject to mandatory registration and transparency requirements, although public disclosure does not extend to full protocols or complete clinical study reports. Under Law No 14,874/2024, clinical research involving humans must be registered in a publicly accessible platform, with information kept up to date throughout the study life cycle. This obligation applies to both medicinal products and medical devices and is imple- mented through national registries integrated with the Brazilian research ethics system. From a sanitary regulatory standpoint, ANVISA RDC No 837/2023 requires that clinical investigations involving medical devices be registered in a public clinical trials database recognised by the World Health Organization (WHO) International Clinical Trials Regis-
In Brazil, clinical trials of pharmaceuticals and medical devices are regulated under a dual oversight model that combines ethics review of research involving human beings with sanitary oversight by ANVISA. The general governance of human research was recently reinforced by Law No 14,874/2024, as regulated by Decree No 12,651/2025 (effective 8 October 2025), which reorganises the national ethics framework and seeks to increase legal certainty and foster clinical research investment. Decree No 12,651/2025 confirms that the current Research Ethics Committee ( Comitê de Ética em Pesquisa – CEP)/National Research Eth- ics Commission ( Comissão Nacional de Ética em Pes- quisa – CONEP) system will remain in operation until the new National Research Ethics Body established under Law No 14,874/2024 becomes fully operational. Ethics and ANVISA reviews are conducted in parallel and are independent, but a trial may only start once the applicable ethics and regulatory clearances are in place. For pharmaceuticals (including biologics), ANVISA’s core framework is RDC No 945/2024, and is struc- tured around submission and life cycle manage- ment of a clinical development dossier for medicines ( dossiê de desenvolvimento clínico de medicamentos – DDCM) and a trial-specific dossier ( dossiê específico de ensaio clínico – DEEC), including requirements for essential supporting documentation (eg, development plan, investigator’s brochure, investigational product quality dossier and statistical analysis plan), safety reporting, amendments and substantial changes, and import logistics (with import documentation support- ing logistics and the formal authorising act published in the Official Gazette). For medical devices, clinical investigations follow a separate ANVISA pathway under RDC No 837/2023, with a risk-based distinction in which higher-risk devices (ie, Classes III and IV) generally require prior ANVISA assent through a clinical investigation dos- sier ( dossiê de investigação clínica de dispositivos – DICD), while lower-risk devices (ie, Classes I and II) are typically not subject to prior ANVISA review and proceed under ethics approval and good clinical prac-
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