Current Regulatory Environment in Brazil

The Brazilian Ministry of Health, through its many divisions, is ultimately responsible for the approval of products and devices registration process, as well as the clinical trials, phase I to III.

The key approval levels for clinical trials are:
  • ANVISA – National Agency of Health Surveillance 
  • CONEP – National Commission of Ethics in Research and institution Ethics Committee/IRB

Brazil is the most regulated country in Latin America. Regulations and guidelines were implemented in early 1996 and keep being updated. ANVISA Resolutions 9/2015 and 10/2015 represent important regulatory progress once cover independent processes and timelines for approvals in clinical trial with drugs and trials with medical devices.

These Resolutions are quite new and pharmaceutical community is still in the learning curve about ANVISA demands assuring efficient timelines for approvals estimated in 90-120 days. CONEP has been strongly remodeled in the last 2 years and has an efficient electronic system (Plataforma Brasil) for clinical trials data submission from Ethic Committee’s directly to CONEP.

The approval timeframe is 60 days, in strict compliance to current guidelines. Both the ANVISA and CONEP approval process run in parallel. ANVISA grants the Importation License right after study approval is released. Each participant site has to obtain local Ethic Committee/IRB approval before to the study procedures start. This approval only happens after CONEP releases the study approval via electronic Plataforma Brasil. All study documents must be in Brazilian Portuguese. Brazil has very good translation companies experienced in clinical trials technical terminologies. The regulatory environment in Brazil is complex and easily takes 6-9 months for all study approvals retrieval.

Brazil has > 200 million people, diverse ethnic population, excellent western medicine, very experienced research centers in both public and private sectors with staff fluent in English, generating reliable data, excellent recruitment and subjects retention in several therapeutic areas – a true Carnival of opportunities.

Presented by Andréa Saud Martinez, Avanti Pesquisa Clinica