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Regulatory evolution and challenges from the perspective of public laboratiories vaccine producers in Brazil
Monique Collaço de Moraes Stávale1, Maria da Luz Fernandes Leal1, Marcos da Silva Freire1
1Instituto de Tecnologia em Imunobiológicos, Fundação Oswaldo Cruz, Rio de Janeiro, Brasil.
Abstract:
The regulation of biological products has evolved rapidly in recent years due to quality issues impacting people's lives and the advent of new technologies, with constant changes in regulations that dictate how a product is registered, produced, and monitored. In the case of vaccines, the responsibility of regulators and manufacturers in guaranteeing quality, safety, and efficacy is even more critical, since vaccines are mostly used in children and healthy patients. In this scenario, manufacturers need to create strategies to keep their products and installations adequate and up-to-date with a fully operational quality system. Meanwhile, regulatory agencies have the role of guaranteeing that products meet the established criteria without compromising the supply of medicines to the population.
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