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O uso de suplementos alimentares por atletas e praticantes de atividade física tem aumentado consideravelmente nos últimos anos. O rótulo é considerado o principal meio de comunicação do fabricante com o consumidor e deve conter todas as informações necessárias de forma compreensível, verdadeira e acessível e não deve conter imagens ou expressões que ludibriem o consumidor quanto as suas funções. O presente estudo teve como objetivo avaliar, segundo parâmetros regulamentares da ANVISA na RDC nº 18/2010, os rótulos de suplementos para atletas comercializados em lojas especializadas de Blumenau-SC das categorias de suplementos proteicos, de creatina ou hidroeletrolíticos. A coleta de dados foi realizada em oito lojas especializadas em comércio de suplementos alimentares para atletas. Foram encontrados e analisados 125 suplementos de proteína, 23 suplementos de creatina e seis suplementos hidroeletrolíticos. Do total de 154 suplementos analisados, 47% possuíam alguma inadequação de acordo com a legislação vigente e 26% possuíam 3 ou mais itens irregulares. O índice de inadequação foi maior na categoria de suplementos de creatina, chegando a 65% da amostra. O modo de apresentação dos dados na rotulagem de forma irregular contribui para induzir o consumidor na escolha do produto e evidencia a falta de fiscalização e aplicação das normas segundo a ANVISA e o Código de Defesa do Consumidor na comercialização dos suplementos alimentares. Dessa forma, verifica-se a necessidade de maior controle e fiscalização dos suplementos comercializados por parte dos órgãos competentes, para que o consumidor possa escolher o produto com segurança e qualidade para sua saúde. ABSTRACT Analysis of supplemental labels for athletes marketed in Blumenau-SC The use of dietary supplements by athletes and practitioners of physical activity has increased considerably in recent years. The label is considered the main means of communication between the manufacturer and the consumer and must contain all the necessary information in a comprehensible, true and accessible manner and must not contain images or expressions that deceive the consumer as to his functions. The present study aimed to evaluate, according to ANVISA's regulatory parameters in RDC nº 18/2010, the labels of supplements for athletes sold in specialized stores in Blumenau-SC that corresponded to the categories of protein, creatine or hydroelectrolytic supplements. The data collection was carried out in eight stores specialized in food supplements for athletes. 125 protein supplements, 23 creatine supplements and 6 hydroelectrolytic supplements were found and analyzed. Of the 154 supplements analyzed, 47% had some inadequacy according to the current legislation and 26% had three or more irregular items. The inadequacy index was higher in the category of creatine supplements, reaching 65% of the sample.The way in which the data are presented on the label in an irregular manner contributes to induce the consumer in the choice of product and evidences the lack of inspection and application of the standards according to ANVISA and the Code of Consumer Protection in the marketing of food supplements. In this way, there is a need for greater control and supervision of supplements marketed by the competent bodies, so that consumers can choose the product with safety and quality for their health.

The regulatory environment for biologics is continuously evolving, because they are ensuring the targeted therapies for many dreadful diseases. But the high cost of biologics has made the European Union to go for the biosimilar development for the first time after the expiration of patents. The strict requirements by the European Medicines Agency (EMA) guaranteed the highest quality standards. These biosimilars are complex in nature and difficult to characterize because they are extracted from the living sources and requires modern biotechnological methods that differ widely from the conventional drugs. The biosimilarity will be assessed based on the comparability studies where there should not be any traces of clinical differences in terms of quality, safety and efficacy. While the Brazil focused mainly on reducing the cost of biosimilar which are essential in treating many rare and specific diseases which lead to the PPD concept for the sake of the public health care system. Two regulatory pathways are emerged for the biosimilars in Brazil in which the molecules that were licensed through the comparability pathway are only considered as biosimilars. The present article summarizes the development process, regulatory perspectives of biosimilars and related issues that may occur due to interchangeability, extrapolation and International non-proprietary names in EMA, ANVISA and also mentioned about the benefits and purpose of Brazil National Health Surveillance Agency (ANVISA) Partnership for productive development (PPD) concept. [ABSTRACT FROM AUTHOR]

Introduction: For 10 years, Brazil has presented a significant flow in cruise ships with 597 011 travelers in 2015. Cruise ships represent a major mass gathering capacity, generating more risk of outbreaks and epidemics. Moreover, visiting several places presents travelers with the possibility of contact with some tropical diseases, which demands the development of specific policies for public health surveillance. Methods: In this study, case reports on transmissible diseases, accidents and deaths on board of cruise ships in the Brazilian coast during 2009 to 2015 were reviewed and correlated with the development of public health surveillance policies implemented by ANVISA, which established the mandatory communication of infectious diseases in 2009 and of deaths onboard in 2011. Results: Norovirus was the major etiologic agent of outbreaks, though the rate of outbreak has been declining in recent years. The lethality rate last season was 0.67:100 000, mostly because of preexisting conditions (75%); the remaining cases were caused by accidents. The mandatory reporting of outbreaks and deaths is an important tool in the planning of preventive actions for the safety and health of travelers in Brazil. The continuous evolution of hygiene surveillance may reduce outbreaks; the adoption of transparency policies and fast communication of deaths has contributed to the significant reduction in accidents. Conclusion: The effectiveness of specific public policies for the safety and security of travelers established for cruise ships in Brazil is indicated by the quantitative reduction in outbreaks and deaths. New destinations such as Cuba and China may adopt the same strategy of surveillance and protection against potential outbreaks of infectious diseases provided by cruise ships.

O registro de medicamentos contempla a avaliação do cumprimento do caráter administrativo da empresa requerente do registro e o caráter técnico-científico relacionado à eficácia, à segurança e à qualidade do medicamento. Esse trabalho buscou identificar os principais motivos administrativos de indeferimento de registro de medicamentos novos, genéricos e similares no Brasil, além de detalhar o procedimento atual de submissão e instrução de processos de registro. Espera-se que, a partir desta análise, futuros peticionamentos possam ser aprimorados e indeferimentos por tais razões, reduzidos. Para isso, foi realizado levantamento das normas vigentes para o detalhamento do processo de submissão de registro e uma análise retrospectiva dos indeferimentos publicados no Diário Oficial da União através do banco de dados da Agência Nacional de Vigilância Sanitária, Datavisa, do ano de 2015. As principais razões de indeferimento por motivos administrativos foram levantadas nos pareceres de indeferimento e constituem o não cumprimento de prazos (61,7%), a avaliação preliminar de processo (19,8%) e a documentação insuficiente para análise técnica (18,5%). A divulgação de tais razões contribui para a transparência do processo regulatório, orientação interna e externa quanto à aplicabilidade dos atos normativos. ====================================== The registration of pharmaceutical drug products involves reviewing company’s administrative aspects as well as technical-scientific aspects related to efficacy, safety and quality. This study evaluated the main administrative reasons for registration refusals of new, generic and similar (branded generic) pharmaceutical drug products in Brazil. Actual submission procedure and process instruction is presented in detail. The aim is to contribute for the improvement of novel applications, reducing non-technical refusals. A retrospective search of registration refusals in 2015 published by the Brazilian Government Official Gazette using Anvisa database, called Datavisa, was performed. The main reasons for non-technical registration refusals of generic and similar pharmaceutical drug products were deadline non-compliance (61.7%), preliminary review (19.8%) and insufficient documentation to permit a substantial full review (18.5%). Disclosure of administrative reasons behind failed applications is a step forward on regulatory transparency, and on internal and external orientation about regulatory mechanisms.

Com o surgimento da pandemia do coronavirus, houve uma dedicação intensa e relevante da comunidade científica à procura de novos medicamentos para tratamentos da Covid-19, devido à inexistência de vacinas e à necessidade emergencial de se evitar os óbitos crescentes em decorrência dos efeitos degenerativos no trato respiratório, provocados pela doença no organismo humano, principalmente nos pacientes do grupo de risco.

Background: Development of novel dermatological topical products for the treatment of cutaneous fungal infections is a constant necessity, especially in developing countries. Through public health policies, many developing countries have facilitated in the last decades the entry of generic products, which can be superficially seen as a threat to innovation. To verify whether regulatory requirements, or the waiving of some requirements, could have an impact on innovation, we performed a detailed technical comparison of the dermatologic antifungal markets of Brazil and of the United States, taking Brazil as an example of a developing country with more lenient requirements regarding the registration of generic topical drug products. Methods: The official databank of ANVISA (DATAVISA) and of US Food and Drug Administration (Orange Book) were assessed for valid topical dermatological antifungal drug products registered. Results: The Brazilian market has a greater number of registered drug products encompassing a greater variety of drug substances than the US, but the latter comprises more products with novel technologies. In both countries, cream was the predominant dosage form and imidazoles were the major substance group. Ketoconazole was the lead active substance in Brazil and ciclopirox was the lead drug in the US. Generic products dominated both markets. Conclusions: Despite the great number of registered products, the Brazilian market lacks the latest technologies, reflecting that the ease of generics registration is not accompanied by innovation. [ABSTRACT FROM AUTHOR]

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Copyright of Chinese Medical Equipment Journal is the property of Chinese Medical Equipment Journal Editorial Office and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Recent therapeutic advances such as immune checkpoint inhibitors (ICIs) have impact on the care of non-small cell lung cancer (NSCLC) patients, however, they bring new setbacks for regulatory agencies. To evaluate the regulatory journey of ICIs registered for NSCLC treatment in Brazil and to establish comparisons of Brazilian regulatory agency with the US regulatory agency. Information for each ICI prescribing as well as the date of regulatory approval of the therapeutic indications of interest were collected from the Anvisa and the FDA websites. The search took place on October 2022. There are only 20 % disagreements on regulatory approvals between Anvisa and FDA. The prioritization review at Anvisa in 2008 has made the regulatory assessment faster. The results of this study identified a potential improvement in Anvisa's time performance to connect the target established by the legal framework of the sector. [Display omitted] • There is a 20% discrepancy between Anvisa and the FDA regarding the regulatory approval of ICI use in treating NSCLC. • Out of 17 shared ICI indications for NSCLC, Anvisa registered two before the FDA. • The prioritization review process adopted by Anvisa in 2008 has made the regulatory assessment faster. [ABSTRACT FROM AUTHOR]

This study analyzes the economics of information and its importance in the current social scenario, called the information society. Information, properly processed and managed, presents itself as a very high value good to society and especially to the economic groups that draw considerable profits. However, the administration of such information with the intention of obtaining or optimizing profits sometimes characterizes violation of basic consumer rights, demanding the adoption of protective postures to these people who often are unaware of the violations of their rights. The research also analyzes one case where it is possible to observe the economic efficiency of information and the ability to generate harm to the consumer, which is the establishment of the medicine traceability system, by ANVISA - National Health Surveillance Agency.

The object of this work is to verify the possibility of the judiciary receive a request for supply of synthetic phosphoethanolamine substance. Through a bibliographical and jurisprudential review, notes that the legalization of public policy has been peaceful when it comes to grant requests for medications, except in the event of lack of therapeutic efficacy of accreditation and patient safety , with its Agency registration national Health Surveillance . It is concluded by no host application providing phosphoethanolamine by the courts due to the lack of legal and scientific support, and should the courts decide legal criteria, not political.

Omega-3 is a polyunsaturated fat considered essential for the body. This compound is SOLD as a nutraceutical in Brazil, being widely consumed by the population due to its functional properties. According to its health benefits, this paper aimed to investigate the labeling of nutraceutical products sold in drugstores in the city of Cascavel, Paraná state - Brazil and verify its compliance with current legislation. The research was carried out in drugstore networks located in Cascavel, Paraná state, in 09 different establishments, from May to June 2016. Nutraceutical products containing omega-3 in their formulations were identified at the sites visited. Their images were captured and proceeded with the research analyzing these labels according to the Legislation in force for products of functional and or health claim. We analyzed 13 labels, only 38.46% (five labels) presented no irregularities. Therefore, it was concluded that the laws in Brazil are not being followed by the companies responsible for manufacturing these products and the lack of mandatory information on their labels can put the consumer´s health at risk, being that it must be guaranteed the consumption safety of adequate and quality products.

A busca da população por alimentos práticos, rápidos e saudáveis tem aumentado a preocupação com a rotulagem nutricional visto que este é o principal veículo de informação ao consumidor sobre as características nutricionais dos alimentos embalados. Este estudo objetivou verificar o índice de conformidades e inconformidades da rotulagem de pães embalados diante das regulamentações vigentes. Para tanto, foi avaliada a rotulagem de 23 pães de forma com informação nutricional complementar disponíveis na região metropolitana de Belo Horizonte - MG. As análises foram realizadas através de uma lista de verificação produzida a partir dos requisitos estabelecidos pela legislação sendo classificados como “adequado” ou “inadequado”. Os resultados demonstraram que 95% dos rótulos analisados foram classificados como inadequado em algum dos parâmetros avaliados, sendo que 26% dos rótulos foram inadequados no parâmetro “Denominação de venda” e 35% no parâmetro “Tabela de Informação nutricional”. O quesito “Informação Nutricional Complementar” obteve o maior número de inadequações concentrando 82,6% da totalidade avaliada. Com base nos resultados obtidos concluiu-se que a falta de entendimento por parte dos fabricantes das leis detentoras da rotulagem nutricional no país entre outros fatores associados, podem explicar as frequentes falhas na rotulagem de alimentos embalados, o que pode ocasionar privação à informação e direito de escolha dos consumidores brasileiros.

Resumo Alergia alimentar é uma reação adversa à saúde, cujas manifestações clínicas podem levar o indivíduo a óbito. Dentre os diversos alimentos que podem ser fonte de alergênicos, pode-se destacar o chocolate. Dependendo da composição, o chocolate pode acumular um grande número de ingredientes alergênicos, potencializando os riscos associados ao seu consumo. O objetivo deste trabalho foi avaliar a rotulagem de chocolates frente à legislação brasileira RDC n.º 26/2015. Os chocolates foram separados em oito categorias, sendo avaliados 139 rótulos. A declaração para alergênico não foi encontrada em 11% dos rótulos, mesmo havendo ingredientes com obrigatoriedade de declaração. As categorias: “chocolate a base de soja” e “confeitos” representaram 40% e 33% dos rótulos não declarados, respectivamente. Pelo menos uma não conformidade frente à RDC n.º 26/2015 foi encontrada em 53% dos rótulos de chocolate, cujas categorias “chocolate diet/light/zero ” e “confeitos” apresentaram não conformidade em 100% e 50% dos rótulos, respectivamente. A declaração em “ local encoberto, de difícil visualização e/ou no lacre/torção ” foi a não conformidade mais recorrente (21% dos rótulos). A legislação deveria ser suficiente para promover um alinhamento na comunicação entre a indústria e o consumidor. Porém, observa-se que a adesão às regras de rotulagem para alergênicos ainda não é completa, mesmo depois de encerrado o período para adequações.

The aim of this study was to evaluate the quality of fish meat in relation to inorganic contaminants (Zn, Pb, Cu, Cr, Ni and Hg), following the Brazilian Health Surveillance Agency (ANVISA) standards in five Amazonian fish exposed to untreated urban sewage. Trace metal concentrations were evaluated in the muscle tissues of Schizodon fasciatus (herbivorous), Potamorhina latior (detritivorous), Triportheus angulatus (omnivorous), Plagioscion squamosissimus (carnivorous) and Rhaphiodon vulpinus (piscivorous), sampled upstream and downstream of Santo Antônio’s Hydroelectric Dam, Madeira River (Porto Velho City, Brazil). An acid chemical digestion was used to extract trace metals from the tissues, and atomic absorption spectrometry methods were used to quantify the trace metal concentrations. Fish samples showed values above allowed limits for Cr (0.10 mg.kg-1 ), except in Plagioscion squamosissimus (0.09 mg.kg-1 ). Potamorhina latior specimens sampled downstream showed higher values for Cr (p

Objetivo: Analisar o monitoramento do teor de sódio em alimentos industrializados coordenado pela Agência Nacional de Vigilância Sanitária e comparar os resultados com as metas de redução de sódio dos acordos voluntários assinados entre o governo brasileiro e representantes das indústrias de alimentos. Método: Utilizaram-se os dados dos quatro informes técnicos sobre o teor de sódio em alimentos processados publicados pela Agência Nacional de Vigilância Sanitária, entre 2010 e 2014. Os informes técnicos foram caracterizados segundo ano de coleta dos dados, Estado, método de análise e número de amostras coletadas por categoria de alimento. Foram descritos os teores de sódio das categorias monitoradas pelo menos duas vezes e comparados com as metas voluntárias estabelecidas. Resultados e Discussão: Do total de categorias de alimentos monitoradas, apenas 39,6% foram avaliadas ao menos duas vezes. Entre as 34 categorias incluídas nos acordos voluntários, 53% foram monitoradas pelo menos uma vez. Mesmo antes do prazo, sete categorias de alimentos possuíam valor médio de teor de sódio abaixo das metas. Verificou-se falta de padronização e pequena abrangência do monitoramento do teor de sódio em alimentos e, consequentemente, dos acordos voluntários. Conclusão: Constataram-se fragilidades no monitoramento do teor de sódio em alimentos industrializados no Brasil, que poderão comprometer a efetividade dessa estratégia regulatória na saúde. -----------------------------------------------------------------------------------------------Objective: To analyze the monitoring of sodium content in processed foods conducted by the National Agency of Sanitary Surveillance (ANVISA) and to compare the results with the goals of sodium reduction of the voluntary agreements signed between the Brazilian government and representatives of the food industry. Methods: We used data from 4 technical reports (TR) on sodium content in processed foods by ANVISA published between 2010 and 2014. We characterized the TR according to the year of data collection, state, method of analysis, and number of samples collected by food category. We described the sodium content of the categories that were monitored at least twice and compared the results with the voluntary goals. Results and Discussion: Of the monitored categories of food, only 39.6% were assessed at least twice. Among the 34 categories included in voluntary agreements, 53% were monitored at least once. Even before the voluntary agreement, 7 food categories had mean sodium content below the targets. We observed that there was a lack of standardization and that the scope of the monitoring of sodium content in foods, and consequently of the voluntary agreements, was limited. Conclusions: Several weaknesses in the monitoring of sodium content in foods in Brazil were detected, which could compromise the effectiveness of the regulatory strategy on health.

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Introdução: Com o objetivo de criar um observatório nos serviços de saúde que funcionasse como referência para monitorar e notificar eventos adversos e queixas técnicas no pós-uso de produtos sujeitos à vigilância sanitária, a Agência Nacional de Vigilância Sanitária (Anvisa), iniciou em 2002, o Projeto Rede Sentinela. Objetivo: Verificar o perfil da Rede no ano de 2016, para nortear a agência para o planejamento de novos credenciamentos. Método: Estudo descritivo e quantitativo, elaborado a partir da coleta de informações dos documentos enviados para Anvisa, pelas instituições de saúde. Resultados: A Rede apresenta 221 instituições credenciadas, que correspondem a 3,0% dos hospitais brasileiros. Estes serviços estão presentes em 24 das 27 unidades federativas do Brasil: 56,0% são hospitais de grande porte e 24,0%, de médio porte. Dos 50 hospitais universitários federais, 23 fizeram adesão à Rede Sentinela e, dentre estes, atualmente 19 são administrados pela Empresa Brasileira de Serviços Hospitalares (EBSERH). Do universo da Rede, 161 são hospitais gerais e 60 são instituições especializadas. Destaca-se que 126 instituições da Rede são certificadas como hospitais de ensino, o que representa 64% dos hospitais certificados pelo Ministério da Educação (MEC). Conclusões: É importante haver uma contínua reflexão quanto à representatividade do conjunto de hospitais sentinela no Brasil com vistas à melhoria contínua da vigilância pós-comercialização. Nesse sentido, faz-se necessário envidar esforços para o credenciamento de outros hospitais, inclusive nos estados sem representatividade, bem como desenvolver novas estratégias de fortalecimento da Rede.

As sementes de Aesculus hippocastanum L. (Hippocastanaceae), conhecida como casta-nha-da-Índia, são utilizadas em várias partes do mundo no tratamento da insuficiência venosa crônica. O objetivo do presente estudo foi avaliar a qualidade de amostras co-merciais de medicamentos fitoterápicos contendo extrato de sementes de A. hippocas-tanum. O total de 16 amostras comercializadas no Brasil com registro válido em março de 2013 foram avaliadas quanto à correspondência com as especificações do dossiê de registro aprovado pela ANVISA. As amostras foram analisadas em Laboratório Oficial, quanto ao perfil cromatográfico, teor de escina, características macroscópicas e micros-cópicas e peso médio. A bula e a rotulagem foram avaliadas por especialista da ANVISA. Os resultados apontaram que 13 dos 16 medicamentos avaliados apresentavam ao me-nos uma não-conformidade. Portanto, é imprescindível a implementação de ações de vigilância sanitária efetivas, com foco no monitoramento e avaliação de medicamentos fitoterápicos ao longo de sua comercialização. ------------------------------------------------------------------- The seeds of Aesculus hippocastanum L. (Hippocastanaceae), known as horse-chestnut, have been used in several parts of the world to treat chronic venous insufficiency. The present study aimed to evaluate the quality of commercial samples of herbal medicines containing extract of A. hippocastanum seeds. In total, 16 commercial samples from Brazilian market with a valid registration in March 2013 were analyzed for the concor-dance with the specifications contained in each application file approved by ANVISA. The fingerprint, the content of aescin, the mean weight and macro and microscopic analysis of these medicines were carried out in an official laboratory. Furthermore, the evalua-tion of the package leaflet and the packaging was achieved by an ANVISA specialist. The results showed that 13 of the 16 commercial samples analyzed were outside of the ap-proved specifications. Therefore, it is imperative that the focus of health activities turn over to the monitoring and evaluation of the herbal medicines throughout its marketing.

Stability studies guarantees that quality attributes will be maintained during a period under the influence of a variety of environmental factors, consequently maintaining drug product efficacy and safety. In this context, stability indicating analytical methods (SIAM) appears as a regulatory requirement to detect common observed impurities and those likely to appear during product shelf-life due to degradation. U.S. Food and Drug Administration (U.S. FDA), The International Council on Harmonization of Technical Requirements for Medicinal Products for Human Use (ICH), World Health Organization (WHO), European Medicine Agency (EMA) have been discussing SIAM concepts and applications, as well as other scientific organisms. Brazilian Health Regulatory Agency (Anvisa) approached SIAM concept through regulations and guidelines in 2015. Hereupon this note intends to expose Brazilian requirements for drug products registration related to SIAM by establishing a comparison to international scenario. [ABSTRACT FROM AUTHOR]

Quality by design (QbD) concept was first outlined by quality pioneer Joseph M. Juran, who believed quality could be designed into a product, preventing, therefore, most quality problems, normally related to the way quality was planned. This concept, as others related to quality conception and management, has already been applied by other industries, as automotive, and later introduced to pharmaceutical industry through US Food and Drug Administration and The International Council on Harmonization of Technical Requirements for Medicinal Products for Human Use guidelines. Brazil mostly applies statistical quality control and still does not have specific regulations regarding QbD, neither other countries in Latin America. Thus, the current stage of pharmaceutical quality regulation in Latin America must be understood to implement better strategies that can positively affect the development of drug products to reach advanced levels of quality. This article reviews aspects related to quality of pharmaceutics and assesses data to analyze whether Brazilian pharmaceutical industry can adapt to this scenario as a pilot for other South American countries. [ABSTRACT FROM AUTHOR]

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Este trabalho objetivou investigar a ocorrência de pedido judicial de medicamento para indicações não aprovadas pela Agência Nacional de Vigilância Sanitária, por meio de ações judiciais contra o Estado de Minas Gerais no ano de 2010. É um estudo transversal, exploratório, com coleta retrospectiva de dados primários. A fonte dos dados foi o parecer técnico referente à solicitação de medicamento realizada por ordem judicial. Os dados considerados foram: patologia informada na ação judicial, medicamento solicitado e a concessão, ou não, de antecipação de tutela ou de liminar. No total de 1.981 pareceres analisados, foram identificadas 212 solicitações de medicamentos para uso off label. Dentre esses medicamentos, 46% não estavam incluídos em programasde assistência farmacêutica do Sistema Único de Saúde. Os medicamentosmais solicitados para uso off label foram micofenolato de mofetila (23%), bevacizumabe (11%) e rituximabe (8%). A classe terapêutica mais solicitada, de acordo com Sistema Anatômico e Terapêutico Químico, foi a dos agentes antineoplásicos e imunomoduladores (54,20%). Dentre os medicamentos solicitados para uso off label, 78,30% foram obtidos por meio de antecipação de tutela ou de liminar. Os resultados apontam para a necessidade de o Poder Judiciário continuar na busca pelo entendimento das questões técnicas que norteiam essas ações judiciais e de os gestores evoluírem na busca pela melhoriada assistência farmacêutica, sem, entretanto, deixar de atender àqueles casos não previstos nos protocolos clínicos, mas que, pelo avanço da ciência e por suas peculiaridades, se mostrarem necessários.

Estudo da legalidade da exigência em licitações públicas, a título de qualificação técnica, de apresentação de Certificado de Boas Práticas de Fabricação e Controle – CBPFC, dos produtos sujeitos à Vigilância Sanitária, documento expedido pela Agência Nacional de Vigilância Sanitária – ANVISA, a partir da legislação brasileira que rege a matéria, contextualizando com a doutrina pátria e o entendimento do Tribunal de Contas da União – TCU. A análise do tema revela o aspecto polêmico da questão e nos permitiu firmar o entendimento pela regularidade da obrigação, pois se conclui que o bem principal a ser tutelado é o direito à saúde dos cidadãos, visto que consumir produto sem a antecedente e imprescindível inspeção sanitária e consequente certificação, pode ocasionar a exposição a grave risco à saúde dos usuários, assumindo maior importância a exigência de qualificação técnica, uma vez que a qualidade do objeto contratado pela Administração Pública está diretamente relacionada à proteção da saúde da população.

O artigo busca apresentar a formação do laboratório de vigilância sanitária no Brasil, a partir da criação do Laboratório Central de Controle de Drogas e Medicamentos (LCCDM), em 1954, e as mudanças ocorridas com a transformação do mesmo no Instituto Nacional de Controle de Qualidade em Saúde (INCQS), em 1981, e posteriormente, com a criação da Agência Nacional de Vigilância Sanitária (Anvisa), em 1999. Discute também as mudanças organizacionais e o seu impacto no controle analítico do risco sanitário dos produtos ofertados à população.

O artigo busca apresentar a formação do laboratório de vigilância sanitária no Brasil, a partir da criação do Laboratório Central de Controle de Drogas e Medicamentos (LCCDM), em 1954, e as mudanças ocorridas com a transformação do mesmo no Instituto Nacional de Controle de Qualidade em Saúde (INCQS), em 1981, e posteriormente, com a criação da Agência Nacional de Vigilância Sanitária (Anvisa), em 1999. Discute também as mudanças organizacionais e o seu impacto no controle analítico do risco sanitário dos produtos ofertados à população.

Health is a topic under discussion. It is a theme with a particular range that must be worked out and discussed since the first steps until old age. As information and education are ways of stimulating the interest and the knowledge of the population on the aspects related to the sanitary monitoring, the Brazilian National Agency for Sanitary Vigilance (Anvisa) conceived the Education and Information Project. It develops educative actions in schools of Primary and Secondary Education starting from the theme health, aiming to increase the level of citizens’ awareness. It considers the multiplying factor represented by the children and the social function of school. This paper presents an experience account developed through an action defined by the Education and Information Project, which aimed to work out the health promotion with primary and secondary students of public schools. Amongst the results the following ones are highlighted: the identification of healthy practices with regard to the preservation of health; the distinction between drugs and medicines; greater awareness of the care with medicines; and obtaining more information on “selfmedication”.

Resenha Nacional

Jurisprudência em Perspectiva. Comentários.

In recent years, nanotechnology has become increasingly important for global industries. Today, many nanomaterials are used as ingredients in cosmetics, food products, medical devices and pharmaceuticals. In some cases they exert unexpected risks and potentially pose a threat to human health and the environment. Regulatory authorities all over the world carefully observe recent developments in this area, striving to find a balance between consumer safety and the interests of the industry. In the following, the current legislation in the United States of America, the European Union, Asia and Brazil will be presented. Further, the requirements defined by these different authorities and methodology to investigate relevant characteristics of nanomaterials will be discussed. [ABSTRACT FROM AUTHOR]

The concepts, importance, and application of bioanalytical method validation have been discussed for a long time and validation of bioanalytical methods is widely accepted as pivotal before they are taken into routine use. United States Food and Drug Administration (USFDA) guidelines issued in 2001 have been referred for every guideline released ever since; may it be European Medical Agency (EMA) Europe, National Health Surveillance Agency (ANVISA) Brazil, Ministry of Health and Labour Welfare (MHLW) Japan or any other guideline in reference to bioanalytical method validation. After 12 years, USFDA released its new draft guideline for comments in 2013, which covers the latest parameters or topics encountered in bioanalytical method validation and approached towards the harmonization of bioanalytical method validation across the globe. Even though the regulatory agencies have general agreement, significant variations exist in acceptance criteria and methodology. The present review highlights the variations, similarities and comparison between bioanalytical method validation guidelines issued by major regulatory authorities worldwide. Additionally, other evaluation parameters such as matrix effect, incurred sample reanalysis including other stability aspects have been discussed to provide an ease of access for designing a bioanalytical method and its validation complying with the majority of drug authority guidelines. [ABSTRACT FROM AUTHOR]

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Copyright of Revista de Sociologia e Política is the property of Revista de Sociologia e Politica and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)