Novos medicamentos registrados no Brasil: podem ser considerados como avanço terapêutico?

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New medicines registered in Brazil: can they be considered as a therapeutic advance?

Cíntia Maria Gava 1
Jorge Antonio Zepeda Bermudez 2
Vera Lúcia Edais Pepe 2
André Luiz Almeida dos Reis 1

1
Agência Nacional de
Vigilância Sanitária,
Ministério da Saúde. SIA,
Trecho 5, Área Especial 57.
71205-050 Brasília DF. [e-mail] 2
Escola Nacional de Saúde
Pública Sergio Arouca,
Fundação Oswaldo Cruz.

Abstract Technological advances in the last century led to the discovery of a variety of medicines.
Their introduction, not always with significant therapeutic gains and not without risk, made the register by regulatory agency an important moment in their evaluation. The aim of this study was to analyze 49 new medicines registered by the
National Health Surveillance Agency (Anvisa), between the years 2000 and 2002 and commercialized in the first half of 2003, considering their therapeutic advantage. Most medicines (42.9%) were from the American pharmaceutical industry. Most of them (63.3%) were classified as a new molecular entity, followed by the new fixed dose combinations (28.6%). Seventy-five percent were registered at the Food and Drug Administration
(FDA). It was possible to obtain the classification of its New Drug Application (NDA) according to their therapeutic potential to 33 medicines and
57.6% of them were classified as standard. Most of the new registered medicines did not provide any therapeutic advantage. It is suggested that Anvisa disseminate the analysis information on innovation, efficacy, safety, brought (or not) by new drugs.
This kind of information is important to consumers, health professionals and health managers.
Key words Health surveillance, New drugs, Medicines, Register, Innovation, Pharmaceutical industry

Resumo Avanços tecnológicos no último século permitiram a descoberta de vários fármacos. Sua introdução, nem sempre com ganhos terapêuticos expressivos e não destituídos de