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. 2019 Jun 24;20(6):235.
doi: 10.1208/s12249-019-1415-y.

Overview of Brazilian Requirements for Therapeutic Equivalence of Orally Inhaled and Nasal Drug Products

Marcia Cavallin Silva  1 , Helena Silveira Costa  1 , Bruna Nardy Valadares  2 , Leticia Grecchi  3 , Lee Nagao  4 , Gustavo Mendes Lima Santos  5
Affiliations

Overview of Brazilian Requirements for Therapeutic Equivalence of Orally Inhaled and Nasal Drug Products

Marcia Cavallin Silva et al. AAPS PharmSciTech. .

Abstract

Brazil has established a framework for provision of generic pharmaceuticals including for orally inhaled and nasal drug products (OINDP) to its populace. This includes the development of guidelines or "resolutions" and normative instructions describing the Brazilian medicines agency's (Anvisa) expectations for demonstrating OINDP therapeutic equivalence. The Anvisa regulatory framework for OINDP therapeutic equivalence, challenges, and comparisons with the US Food and Drug Administration and European Medicines Agency approaches are assessed and discussed.

Keywords: Anvisa; nasal drug products; orally inhaled drug products; therapeutic equivalence.

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