Key Implications In Brazilian Regulatory Environment From The Innovation Point Of View | 19089
Pharmaceutical Regulatory Affairs: Open Access
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The regulatory environment is naturally influenced by multiple factors. International experience shows that the chain of
innovation in the pharmaceutical industry depends on an efficient regulatory framework in order to be well-developed.
Moreover, it has been recognized as the key factor in competitiveness between companies and countries. However, in developing
countries, the innovation process is not aligned with the real interests of the public health sector. This paper aims to clarify
the innovative flow of pharmaceutical chain and its main actors, with special emphasis on the comparison of the regulation of
innovative countries with the current regulation of Brazil. The paper also presents a critical analysis of the Brazilian regulatory
framework, as well as suggestions to improve regulation in the various levels at which regulation is related to the development
of innovative drugs. In the case of pharmaceutical companies, innovation means a new drug, commercially available, for
human consumption in order to treat a disease. Discover a new active ingredient, or a new molecule, is an invention of a new
chemical entity, but is only an innovation when it has been proven to combat the disease effectively, and consumption is made
possible through a new drug into the market. In practice, the Brazilian market is supplied by imports of innovative products/
technologies. From this perspective, what Brazil should do to be innovative in pharmaceutical market?.
Suzana de Lima R de Deus has completed her graduation from Bezerra de Ara?jo University and Master Business Administration (MBA) studies from Rio de
Janeiro Federal University. She is doing her Master?s degree in National Institute of Intellectual Property. She is the senior analyst of Actelion Pharmaceuticals do
Brasil, a biopharmaceutical company. She has presented more than 15 papers in reputed events.
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