[The challenges of nanotechnology for the sanitary vigilance of medication]. / Os desafios da nanotecnologia para a vigilância sanitária de medicamentos.

The development of effective and safe nanotechnology medication with a high cost-benefit ratio is a strategic imperative for public health in Brazil. The lack of information demands sanitary regulation geared to protecting health and the environment. This study seeks to assess the current stage of development, the regulatory framework and the challenges facing nanotechnology medication in Brazil, emphasizing sanitary surveillance. Document analysis was conducted in national and international regulatory agency sites. Despite the incipient regulation for this type of medication, 7 registered nanotechnology products were found in Brazil, without clear identification on leaflets or packaging regarding their nanotechnology composition, as well as 4 similar products. Risk assessment and regulation of such medication requires specialized personnel and equipment, as well as the participation of society in the formulation and implementation of regulatory policies. The suggestion proposed is that the regulatory framework should follow the precautionary principle, whereby products are registered as new medication with clear information on the labeling and controlled usage, until further results on the assessment of risk are obtained.

Os desafios da nanotecnologia para a vigilância sanitária de medicamentos / The challenges of nanotechnology for the sanitary vigilance of medication

No Brasil, o desenvolvimento de medicamentos nanotecnológicos eficazes, seguros e com alta relação custo/benefício é estratégico para a Saúde Coletiva. A falta de informações requer uma regulação sanitária voltada à proteção da saúde e do ambiente. Objetiva-se identificar o estágio de desenvolvimento e o marco regulatório dos medicamentos nanotecnológicos e seus desafios no Brasil, enfatizando a segurança sanitária. Foi realizada uma análise documental em sítios de agências reguladoras, nacional e internacionais. Apesar da incipiente regulação destes medicamentos, foram encontrados 7 registrados, no Brasil, sem identificação clara na bula e na embalagem quanto às suas constituições nanotecnológicas, e 4 como medicamentos similares. A avaliação de risco e a regulação desses medicamentos exigem pessoas e equipamentos especializados, bem como a participação da sociedade na definição e implementação das políticas regulatórias. Sugere-se que a regulação considere o princípio da precaução, sendo o registro feito como medicamento novo e com informação na rotulagem e uso monitorado, de forma que sejam obtidos novos resultados sobre a avaliação de seu risco.

The development of effective and safe nanotechnology medication with a high cost-benefit ratio is a strategic imperative for public health in Brazil. The lack of information demands sanitary regulation geared to protecting health and the environment. This study seeks to assess the current stage of development, the regulatory framework and the challenges facing nanotechnology medication in Brazil, emphasizing sanitary surveillance. Document analysis was conducted in national and international regulatory agency sites. Despite the incipient regulation for this type of medication, 7 registered nanotechnology products were found in Brazil, without clear identification on leaflets or packaging regarding their nanotechnology composition, as well as 4 similar products. Risk assessment and regulation of such medication requires specialized personnel and equipment, as well as the participation of society in the formulation and implementation of regulatory policies. The suggestion proposed is that the regulatory framework should follow the precautionary principle, whereby products are registered as new medication with clear information on the labeling and controlled usage, until further results on the assessment of risk are obtained.