Clinical Trial Approval Process in Brazil – Clearing the Roadblocks to International Studies
Brazil’s health statutes have grown over the years since inception and now include approximately 20 regulations at the national level, from the Brazilian Ministry of Health and the National Ethics Committee, as well as the international requirements included in the International Conference on Harmonization (ICH), principles of Good Clinical Practice (GCP), and the Helsinki Declaration.
The complexity of the Brazilian human health regulatory environment originated from the country’s concern for the safety of its people as potential participants in international studies. The socioeconomic disparity in certain regions of Brazil relative to the countries of origin of the pharmaceutical sponsors of clinical trials was seen as a potential enticement for study participation that may disguise the risk.
As a result, the regulation of clinical research in Brazil ensures a high ethical standard comparable to internationally accepted benchmarks, yet has resulted in a lengthy process, slow to reach its conclusion due to the requirement for several independent and somewhat redundant reviews and approvals.