Regulatory law: regulation marks evaluation on biotechnology based drugs launching in Brazil


Regulatory requirements for the pharmaceutical industry have been increasing a lot in recent decades, sometimes because of the new therapies that show to be more specific and with less adverse effects, mainly for the biologicals. The regulatory system might be a big issue for many countries where there are no harmonized requirements and, due to the globalization processes in the last years, the production does not happen in the same environment of the end user. The intention of this project was to evaluate the consequence of the recent regulatory changes for the Research, development and launching of biologicals in the Brazilian market. A questionnaire was applied to private and public pharmaceutical companies in Brazil, among Brazilian or foreign ones. It could be observed that the regulatory mainframe in the last years brought up some change on this market in brazil, mainly with a greater participation of national private companies and with an increase in the Brazilian public industrial sector.

CABRAL, Claudio Henrique Damasceno; DERENZO, Silas. Direito sanitário: avaliação de marcos regulatórios sobre lançamento de medicamentos de base biotecnológica no Brasil. Revista da Faculdade de Ciências Médicas de Sorocaba, v.22, n.1, 8p., 2021.

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