Impact of trial design on GCP inspections - World Health Organization

REGULATORY OVERSIGHT OF CLINICAL
TRIALS POST AUTHORIZATION
•Protocol amendments should be submitted to ANVISA and
authorized by the ethics committee prior to implementation
•The sponsor must submit annual and final reports to ANVISA
The non-submission <strong>of</strong> annual reports implies the immediate
cancellation <strong>of</strong> the CE
Agência Nacional
de Vigilância Sanitária
www.anvisa.gov.br