Brazilian national health surveillance agency publishes new rules on clinical trials for drug marketing authorization
Summary
On December 2, 2024, the Brazilian National Health Surveillance Agency (ANVISA) published the Resolution (RDC) no. 945/2024, establishing new guidelines and procedures for conducting clinical trials in Brazil aimed at granting drug marketing authorization. The new rule proposes an alignment of the matter with Federal Law no. 14.874/2024 and the reductions of bureaucratic barriers to clinical drug development, making Brazil more attractive to the sector.
RDC no. 945/2024 is accompanied by Normative Instruction (IN) no. 338/2024, which provides the list of Equivalent Foreign Regulatory Authorities (AREE) and the criteria for adopting an optimized analysis procedure for granting clinical drug development process (DDCM), clinical research process (DEEC), substantial modification to the investigational product, and substantial amendment to the clinical protocol.
Both regulations will come into effect on January 1, 2025. RDC no. 945/2024 will revoke RDCs no. 9/2015 and no. 449/2020.
Among the news introduced by RDC no. 945/2024 and IN no. 338/2024, we highlight:
- The express provision of independence between ethical and regulatory approvals, allowing applications to be submitted in parallel to the ethical and regulatory instances, in harmony with Federal Law no. 14.874/2024. Despite the possibility of independent submission, the trial for drug marketing authorization purposes can only begin after ethical and sanitary approval.
- The waiver of Clinical Trial Notification for post-marketing trials (phase IV) and non-interventional clinical research, which are only subject to ethical approval.
- The definitions of clinical trial risk levels (low, moderate, and high), as well as the concept of “complex clinical trial”.
- The harmonization of national regulatory practices with standards recommended by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), according to the ICH E6(R2) Good Clinical Practice Guide.
- The possibility of anticipating the importation of investigational drugs. ANVISA will authorize the importation of investigational products within 30 business days from the date of the DEEC application, before the approval or rejection of the DDCM and DEEC applications. In the case of early importation, the products will be under the sponsor’s responsibility and can only be distributed to research sites after the publication of the DDCM and DEEC application approvals in the Official Gazette.
- The optimized procedure for analyzing applications based on regulatory trust practices (Reliance), according to clinical protocols already approved by the AREEs, and based on risk assessment supported by the experience of using the experimental drug, aiming at speed and reduction of duplicate analysis.
- The confirmation that the sponsor must notify, through the electronic notification system provided by ANVISA, all Suspected Unexpected Serious Adverse Reactions (SUSAR), defined as adverse reactions that simultaneously meet the conditions of serious, unexpected, and with a reasonable possibility of causal relationship.
Although the legislator intentionally excluded the investigator-sponsor from Federal Law no. 14.874/2024, ANVISA maintained the definition and continued to allow clinical trials conducted and coordinated by investigator-sponsors to be developed with financial resources from private entities (among other sources).
Finally, as part of the regulatory transition period, the analysis and approval of applications submitted to ANVISA before the publication of the new regulations and still awaiting technical analysis will be evaluated according to the rules and requirements in effect at the time of submission, and the application may be requested to be adjusted to the optimized analysis procedure.
