New rules for phytopharmaceutical drug registration in Brazil.

ABSTRACT

Although it is among the ten largest pharmaceutical markets in the world and has the most diverse flora, few efforts have been made in Brazil in order to assure legal rules, which are able to provide phytotherapeutical products with efficacy, safety and constant quality. Only in the last 3 years has the Ministry of Health convened an expert commission to evaluate the existent legal requirements for such products and to provide modern and effective legislation. The results of this work and the consequences of its implementation are discussed in this article.