Plant-made pharmaceuticals and their impact on food security: Gap analysis of the current regulations

• Autor(a) principal: Guimarães, Rosane Cuber
• Data de Publicação: 2014
• Outros Autores: Freire, Marcos da Silva, de Almeida, Antonio Eugenio Castro Cardoso
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Vigilância Sanitária em Debate
• Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/399
• topic: Genetically Modified Plants; Plant-made Pharmaceuticals; Food Security; Regulation; Gap Analysis; Plantas Geneticamente Modificadas; Plantas Produtoras de Biológicos; Segurança Alimentar; Regulação; Análise de Lacunas

The use of genetically modified plants to synthesize proteins that are subsequently processed, regulated, and sold as pharmaceuticals is already a global reality. However, the issue of technological development and industrial production of biological products being expressed in transgenic plants and their impact on the safety of the food chain needs to be discussed more deeply. In this paper, we present an extensive literature review on the standards and regulatory guidelines as well as on biosafety in Brazil with regard to the production of plant-made pharmaceuticals; compare them with the regulatory guidelines of other countries/regions such as USA, Canada, European Union, Cuba, and Argentina; and analyze gaps in the Brazilian regulation. . We suggest that some regulations must be reviewed and conclude that the Brazilian regulatory authorities should establish an interrelated regulatory framework together, which would enable industrial production while protecting human and animal health as well as the environment.