Brasília – Brazil’s National Health Surveillance Agency (ANVISA) published, on December 26, a Questions and Answers (Q&A) document addressing the application and interpretation of Resolution of the Collegiate Board (RDC) No. 945/2024, which establishes rules and procedures for the conduct of clinical trials in Brazil. The material is intended to clarify recurring questions raised by the regulated sector following the entry into force of the new regulation.

According to ANVISA, the Q&A covers aspects related to the scope of RDC 945/2024, including types of clinical trials subject to the rule, documentation requirements, and the roles and responsibilities of sponsors and other stakeholders involved in clinical research activities conducted in the country.

The document also addresses provisions of Normative Instruction (IN) No. 338/2024, which complements RDC 945/2024 by detailing criteria and procedures for optimized regulatory analysis of clinical trial submissions. The Q&A consolidates guidance on how the two normative acts should be applied in practice.

The questions and answers were compiled based on inquiries received by the agency and are available on ANVISA’s website as a support tool for stakeholders involved in clinical research under the new regulatory framework.

Source: ANVISA