BRAZIL
Regulatory and Ethical Procedures
Brazil's regulatory authority, the National Health Surveillance Agency (ANVISA), was created in 1999 with the aim to protect and promote the population's health and to ensure the safety of products and services.


Health Care System

Brazil, with a population of about 180 million, is the largest and most populous country in South America. This enormous population offers significant advantages for recruiting patients for clinical trials, due to the ethnic diversity and the large number of treatment-naive patients within the population.

Healthcare facilities vary widely from region to region. Brazil has several state-of-the-art hospitals, in particular in Sao Paulo and Rio de Janeiro, two of the largest cities in the world. A growing number of well-qualified investigators with knowledge of ICH guidelines and GCP standards are available.

The healthcare system is two-tiered. All Brazilian citizens are entitled to free medical assistance through the Unified Health System, SUS (Sistema Único de Saúde). Those who can afford it have access to the private healthcare sector, which complements the public healthcare services and covers about 25% of the population.


Authorities

Ministry of Health

National Health Surveillance Agency, ANVISA (Agencia Nacional de Vigiláncia Sanitária)

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