University of Hertfordshire

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Original languagePortuguese
JournalRevista acadêmica - Oswaldo Cruz
Publication statusPublished - 1 Dec 2017


This article had the objective of analyzing the regulatory mark for the implementation of the registration of pharmaceutical inputs as of the publication of RDC 57/09. The evaluation of the history of Brazilian regulation and the results obtained with the registration requirement, mainly in relation to international inspections, made it possible to draw a vision of the impacts in the pharmaceutical market as well as the perspectives for the future of the sector. The methodology used for the research was through a bibliographical review and used as source articles from other authors related to the subject and public and private data. The results showed the prevalence of imported APIs for the production of medicines in Brazil, pointing to a slow evolution of an expected higher self-sufficiency of the national industries of APIs. Although the regulation of registration of active pharmaceutical inputs represents a mechanism of regulatory isonomy between Brazil and other countries, it should be pointed out that this is only one of the needed tools for the strengthening and development of the national industries of APIs.

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