New regulations for clinical trials in Brazil

Aimed at speeding up the start of clinical trials for the development of new drugs and health products, Regulations RDC 09/2015 and 10/2015 were published on March 3, 2015, in the Official Gazette.

The new regulations, which revoke the previous RDC 39/08, take on a regulatory model in line with the main international health agencies regarding the submission of technical documentation and good clinical practice. They are also aimed at providing higher quality and administrative efficiency in the assessment of clinical tests by the Brazilian Health Authority (ANVISA).

One of the new features introduced by the regulations is the establishment of a fixed deadline for ANVISA to perform the evaluation of the drug clinical development dossiers (DCDD), which contain the projects of clinical trials to be performed in Brazil. This text containing the phase III clinical trials with synthetic drugs and carried out in other countries will now have to be reviewed by ANVISA in a maximum of 90 days.

This new rule also establishes that in those cases where ANVISA does not respond within 90 days, the study can be started, provided it has been approved by the authorities that assess the ethical aspects of the research. Requests for authorization currently awaiting technical evaluation and already in ANVISA prior to the validity of this regulation, also fall under this 90-day rule.

Phase I and II clinical trials with biological drugs or carried out only in Brazil, will have to be reviewed by ANVISA within 180 days. However,in this case the study cannot be started until it has been evaluated by the agency.

The new regulations seek to harmonize clinical trials in Brazil with other international standards and agencies. They are also aimed at encouraging the integration of Brazil in research that is carried out simultaneously in other countries.

These new regulations are the result of a public consultation carried out in 2014 among the Brazilian clinical research sector and, that received 641 contributions.