Regulatory framework of nanopharmaceuticals in developing countries: An analysis of the current rules in Brazil

Abstract Nanotechnology has emerged as an alternative technology to contribute with innovation, and nanomedicine has the potential for providing a great and direct impact in quality of life through the development of nanopharmaceuticals. It represents a billion-dollar market because its related innovations may generate multifunctional entities with improved qualities. However, this promising technology may be accompanied by risks, representing a challenge to those dealing with technological development and its regulation. This chapter provides an analysis of the current rules of nanopharmaceuticals in Brazil, with the objective of putting forward multilateral cooperation, including intellectual property rights and regulatory issues. Although Brazil has already authorized the registering and marketing of nanopharmaceuticals, it currently has no specific regulation. This leads to difficulties in defining which tests pharmaceutical companies should perform and what government agencies should request in order to guarantee their safety. Consequently, we suggest alternatives to pharmaceutical companies developing innovation in this complex scenario.