Abstract
Introduction: The sanitary registration is a precondition for the commercialization of a medicine in the national market. Objective: This manuscript makes a critical analysis of Brazilian sanitary legislation to subsidize the obtainment and adaptation of registration of medicines destined to neglected diseases. Method: The development of this article was based on a critical analysis of the legislation available on the website of the National Agency of Sanitary Surveillance (Anvisa). This analysis was compared with international guidelines, in addition to the daily practice of the Regulatory Affairs Sector of an Official Pharmaceutical Laboratory. Results: The data obtained showed that there is no specific legislation for registration and post-registration of medicines for neglected diseases. Thus, there are gaps in the legislation applicable to these drugs. The absence of reference drugs in Brazil, and the lack of active ingredient suppliers that comply with current legislation, impairing the adequacy of these registries and obtaining new record are examples of the existing gaps. Conclusions: Nowadays, keeping a record of this class of medicine at Anvisa becomes a significant challenge, and each registry must be explicitly treated with the regulatory agency.
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