A recent AAPS Open article examines Brazil’s new regulatory agency.
Brazil is the largest country in South America with a population of over 200 million people. Brazil has become the second largest pharmaceutical market in the emerging world, with an expectation of economic growth between 7 and 10% annually until 2020.1 Global bio/pharmaceutical companies are highly interested in investing in this vast and growing market. However, this opportunity may present a significant challenge when navigating through the complex Brazilian regulatory process.
The Brazilian Health Surveillance Agency, commonly known as ANVISA, abbreviated from Portuguese “Agencia Nacional de Vigilancia Sanitaria,” is the food and drug regulatory agency in Brazil. ANVISA’s primary goal is to protect and promote public health by exercising health surveillance over products and services, including processes, ingredients, and technologies that pose any health risks.
ANVISA is responsible for drug registration and licensure of pharmaceutical laboratories and other companies inside the pharmaceutical production flow. The agency is also responsible for establishing regulations applicable to clinical trials (with regards to drugs chemistry, manufacturing, and control [CMC] and subject safety). In conjunction with the Health Ministry and other ministries members, ANVISA works with the Chamber of Drug Market Regulation to regulate drug pricing. Ethical human clinical trials are in turn regulated by an Ethics Committee linked to the Health Ministry. ANVISA controls a broad diversity of health-related areas, as shown in Table 1.
This article was adapted from ANVISA: an introduction to a new regulatory agency with many challenges, by Kim Huynh-Ba and Alexandra Beumer Sassi, under CC BY 4.0.
REFERENCES
- Afonso P, Dreszer J, Francies T, Ramos P. Maintaining momentum in Brazil’s pharmaceutical market. McKinsey & Company Pharmaceuticals & Medicinal Products.