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Clinical Research & Pharmacovigilance in Brazil

Clinical Research in Brazil
The Brazilian Senate approved the Senate Bill PLS 200/2015 that aims to accelerate the approval and release of clinical research in Brazil.
Brazil has favorable conditions to become an advanced research center. Its biodiversity - the largest in the world - increases the country’s potential for investment. To better take advantage of these resources, a policy that emphasizes Innovation, encouraging investments, a more intense exchange between Brazilian and international researchers and, especially, a defined, stable regulatory framework that adequately protects intellectual property is needed. The actions of the Ministry of Health to expedite the approvals of the Clinical Studies in Brazil have improved the local environment for this investment. Both CONEP (National Commission for Research Ethics) and Anvisa have reduced approval periods for local clinical studies, but there is a need to modernize regulatory frameworks and better define the rights of research subjects
According to number of clinical studies registered in Brazil are 7,411.
Clinical trials in Latin America is proceeding with high growth because of their ability to meet the requirements for subject enrolment as well as availability of qualified investigators. Clinical data management in Brazil is projected to experience significant growth from 2019 – 2025. Outsourcing of clinical trials will boost clinical data management. With increasing development of advanced drugs in Brazil, the demand for clinical data management will increase.
Pharmacovigilance in Brazil
According to some reports, Pharmacovigilance market will exceed US$10 Billion by 2025. Increasing drug consumption and rise in Adverse Events / Serious Adverse Events will escalate the need of Pharmacovigilance services. Growing Pharmacovigilance activities carried out pharmaceutical companies for drug safety testing services will drive Pharmacovigilance market growth. Brazil with growth pharmaceutical market will have significant share of the pharmacovigilance services markets.
Health regulation is an important tool to guarantee the quality and safety of medicines, and consumer protection, without creating unnecessary restrictions for the industry. To achieve this mission, regulators need to equip themselves with sufficient trained staff and infrastructure (especially Information Technology) to perform their role comprehensively and effectively. Today Anvisa is recognized as one of the best health agencies in the world.
The creation of the National Drug Control System, through Law 11,903/2009, amended by Law 13,410, of December 28, 2016, contemplated the permanent position of the pharmaceutical industry in favour of improving the traceability mechanisms of medicines sold in the country. In 2017, RDC No. 157/2017 was published, which provides for the implementation of the National Drug Control System and the mechanisms and procedures for drug tracing, which is in the experimental phase.
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