June 2018: Brazil Regulatory Update

As stated in ResolutionNo9 and ResolutionNo222, applicants are responsible for paying a Proof of Deposit Health Surveillance Rate (TFVS) fee to submit a clinical trial application to the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA).

According to Additional Resource (B), the amount of TFVS fee depends on the size of the organization submitting the application. Per Additional Resource (B), the fees range from R$1,421.70 to R$28,433.93 BRL. According to Additional Resource (C), ANVISA’s fee expires after six (6) months for the first study site approved. The applicant must pay an additional TFVS for each new site included following this expiration.

(A) (Document) Surveillance Fee (TFVS) Frequently Asked Questions (Version 1.1) (Portuguese) (Last Updated May 28, 2014)
ANVISA, Ministry of Health, Federative Republic of Brazil
(B) (Document) New TFVS Values (Version 1.0) (Portuguese) (Last Updated June 13, 2016)
ANVISA, Ministry of Health, Federative Republic of Brazil
Relevant Sections: 4.7
(C) (Website) Global Health Regulatory Requirements Database – Brazil: Drugs (Last Updated November 18, 2014)
Global Health Technologies Coalition

Leave a Reply