BRAZIL Law and Practice Contributed by: Priscila Kashiwabara, Viviane Trojan, Gustavo Vicenti and Giovanna Mezher, Kasznar Leonardos Intellectual Property
• RDC 505/2021 (amended by Normative Instruction 270/2023) governs clinical trials for advanced therapy medicinal products. Clinical Trials for Medical Devices • Law 14.874/2024 provides for research involving human subjects and establishes the National System of Ethics in Research with Human Subjects. • RDC 837/2023 regulates medical device tri- als. • RDC 751/2022 (in force but amended by RDC 777/2023 and 810/2023) defines risk classifi- cation, notification, labelling and use instruc- tions. 2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial Pharmaceuticals For ANVISA approval of pharmaceutical trials, sponsors must submit a Drug Clinical Develop- ment Dossier (DDCM) as per RDC 945/2024. ANVISA’s Co-Ordination of Research and Clini- cal Trials department (COPEC) assesses the DDCM for sanitary risks before approval. ANVI- SA aims to complete its analysis within 90 days. Sponsors must also provide detailed protocols to the Research Ethics Committee (CEP) before trials commence. Imported products for human research must also obtain ANVISA approval, with sponsors maintaining responsibility for data integrity and quality, even if functions are dele- gated to a Clinical Research Organisation (CRO). It is worth noting that Law 14,874/2024 estab- lishes a new deadline of 90 days for ANVISA’s analysis of primary petitions for clinical trials with human beings. Medical Devices RDC 837/2023 simplified medical device clinical trials in Brazil, aligning with international stand-
ards and clarifying ANVISA approval require- ments. This regulation eliminates the need for Clinical Research Process Consent and expe- dites approvals by consolidating documenta- tion under a single Medical Devices Clinical Research Dossier (DICD) process. This stream- lining removes the necessity for CEP opinions, simplifying paperwork. Only trials with results that could support Class III and IV medical device registration in Brazil necessitate ANVISA submission. 2.3 Public Availability of the Conduct of a Clinical Trial ReBEC ( Registro Brasileiro de Ensaios Clínicos ) is the official Brazilian Registry of Clinical Tri- als, operated by ANVISA. It is a public platform where anyone can find details about clinical tri- als conducted in Brazil, including study design, participant criteria and contact information. The database contains information such as trial title, sponsor, investigational product, phase, pri- mary and secondary endpoints, inclusion/exclu- sion criteria and participating research centres. Health data is considered sensitive under National Research Ethics Committee (CONEP) Resolution 466/2012 and Law 13,709/2018, also known as the General Data Protection Law ( Lei Geral de Proteção de Dados Pessoais or LGPD), mandating confidentiality for trial participants’ data in both public and private institutions. Sponsors must document and report adverse events, especially fatal or life-threatening ones, to ANVISA electronically within seven days of becoming aware of them (RDC 945/2024). Section II, subsections I and II of RDC 945/2024, specify that sponsors must submit annual moni- toring reports on the trial drug’s progress, detail-
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