Author:

• Kelen Soares - Soares, Kelen - Anvisa, Coordenação de Bioequivalência - <kelen.soares@anvisa.gov.br> +

Co-author(s):

• Tais Gratieri - Gratieri, Tais - UNB - <tgratieri@gmail.com>
• Guilherme Martins Gelfuso - Gelfuso, Guilherme Martins - UNB, Faculdade de Ciências da Saúde - <gmgelfuso@yahoo.com>
• Marcelo Vogler - Vogler, Marcelo - UNB, Faculdade de Ciências da Saúde - <vogler_bsb@yahoo.com.br>

Thematic Area:

Informação e Comunicação em Saúde

Abstract:

Comparative evaluation required for generic topical medicines registration in Brazil is performed by a pharmaceutical equivalence study, assessing only physical chemical parameters and microbiological aspects of the formulations. Internationally, clinical or pharmacodynamic studies have been required to prove the efficacy and safety of topical semisolid generic formulations. This work presents a comparison of the topical formulations requirements for registration, considering different regulatory authorities, and presents a data collection of topical medicines registered in Brazil up to 2013. Larger amount of copies registered in Brazil in comparison to the USA is shown by such data collection. This fact together with the large number of studies in the literature showing different efficacies between generic and reference products, evidence the importance of the Brazilian legislation readjustment concerning technical requirements for registration of copies of original dermatological topical products.

Keywords:

Bioequivalence Topical Medicine Anvisa

Content:

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