Medicines evaluated by Fantástico have been approved by Anvisa

PRESS RELEASE São Paulo, January 27, 2017 Regarding the testing of generic drugs carried out by the Center for Pharmaceutical Studies and Analytical Development (CEDAFAR) at the request of TV Globo's Fantástico program, we hereby inform that: The drugs evaluated are duly registered and comply with all quality and safety requirements recommended by law and by Anvisa (Brazilian Health Regulatory Agency). All drugs evaluated by the report were subjected to new tests by manufacturers in laboratories authorized by Anvisa and proved to be fully compliant with the quality standards determined by the regulatory agency. According to a statement issued by Anvisa in response to the report, the tests conducted by Fantástico did not follow the appropriate technical and regulatory requirements. Also according to Anvisa, CEDAFAR is not accredited to perform the tests requested by Fantástico. All generic drugs available on the Brazilian market undergo bioequivalence tests (performed on humans) and pharmaceutical equivalence tests, which guarantee their efficacy and safety. The generic drug production complex is also subject to strict control rules, which include, among other requirements, Good Manufacturing Practice Certifications, audits and internal controls, and systematic pharmacovigilance programs, which are also carried out by the companies themselves. The regulatory framework is completed by the National Drug Quality Verification Program (PROVEME), established by ANVISA (the Brazilian Health Regulatory Agency), and other quality and safety control tools, such as the Consumer Accident Information System (SIAC), created by the Ministry of Justice and the Ministry of Health. This entire set of measures and control systems, which aim to detect and prevent any non-compliance, guarantee and safeguard consumer interests, has been strictly enforced by ANVISA – the regulatory agency, reinforcing the quality and safety guarantees for all drugs produced in the country, whether they are generic, similar, or reference drugs.