Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants to better organize the proposal. Methods. A retrospective search of drug products registration processes was performed on the Brazilian Government Official Gazette from January 1, 2015, and December 31, 2015. Results. Drug product quality control, drug product stability study, deadline accomplishment, API quality control made by drug manufacturer, active pharmaceutical ingredient (API), and production report were the main reasons for marketing authorization application refusal of generic and similar pharmaceutical drug products in 2015. Conclusion. Disclosure of the reasons behind failed applications is a step forward on regulatory transparency. Sharing of experiences is essential to international regulatory authorities and organizations to improve legislation requirements for the marketing authorization of generic and similar pharmaceutical drug products.
Resumo As doenças relacionadas ao tabaco matam oito milhões de pessoas anualmente no mundo e, no Brasil, são responsáveis por milhares de casos de cânceres, doenças cardiovasculares e outras enfermidades. Os filtros nos cigarros são percebidos como uma tecnologia que reduziria os danos à saúde. O objetivo deste artigo é descrever a tecnologia dos filtros, seu histórico, seus impactos e discutir formas de regulação. Foi feita uma busca na literatura para avaliar os impactos desta tecnologia. Os resultados mostram que os filtros foram inicialmente desenvolvidos para fins estéticos, e posteriomente aprimorados e promovidos como uma tecnologia para redução de danos. O filtro de cigarro mais utilizado é o de acetato de celulose, combinado ou não com carvão ativado. Apesar das propagandas e da percepção dos fumantes, os filtros não trazem nenhum benefício à saúde, e sua associação com tecnologias como a perfuração nas ponteiras podem trazer mais riscos à saúde. Os filtros também podem tornar os cigarros mais atrativos e causam impactos ao meio ambiente. Por proporcionarem uma falsa percepção de riscos e nenhum benefício, os filtros deveriam ser uma tecnologia proibida.
ObjectiveTo investigate the perceptions of young people and adults, smokers and non-smokers about the current set of innovations introduced in 2018 into the Brazilian tobacco products’ health warnings.MethodsTwenty focus groups were conducted in five state capitals in Brazil. The participants (n=163) were segmented by smoking status, age (15–17 years, 18–55 years) and social grade (C, D–E classes) to examine cigarette packaging and explore the participants’ perceptions of health warnings.ResultsHealth warnings capture attention, eliciting apprehension, fear, disgust and concern about the negative consequences of cigarette consumption. The 2018 Brazil health warnings are spontaneously recalled by participants, even without the presence of cigarette packages. However, the analysis also reveals the challenges of overcoming communication barriers and distorted interpretations, especially among smokers. The inclusion of direct and provocative stimuli, such as the use of the word ‘you’, attracts attention and creates more proximity to the recipient of the message. The results also highlight the interest and fear elicited by warnings on toxic constituents and the importance of using contrasting colours in warnings, which differentiate them from the colours of cigarette packs.ConclusionIntroducing innovative components in health warnings can catch consumers’ attention but considering that the interviewees encountered difficulties interpreting textual warnings about toxic constituents in cigarettes, the study reinforces the importance of adopting direct language and pictures, instead of text, which can visually transmit the warning messages and the use of specific wording that generates proximity between the emitter and receiver.
establishing a working group to assess the possibility of tax cuts on cigarettes manufactured in Brazil, aimed at "decreasing the consumption of low-quality foreign cigarettes, contraband, and the resulting health risks". According to the Ruling, the working group would address such topics as proposals to reduce the consumption of these cigarettes and even the possibility of reducing taxes on those manufactured inside Brazil to avoid the consumption of "low-quality" foreign cigarettes. The scientific basis cited for the working group's implementation was the study entitled Uma Alternativa de Combate ao Contrabando de Cigarro a partir da Estimativa da Curva de Laffer e da Discussão sobre a Política de Preço Mínimo [An Alternative for Combatting Cigarette Contraband based on the Laffer Curve Estimate and Discussion of the Minimum Price Policy] 2. The above-mentioned document states that contraband cigarettes do not display the same quality as legal Brazilian cigarettes and are thus more harmful to health, and that illegal trade accounts for more than half of the Brazilian cigarette market. The working group includes representatives from the Federal Police, National Consumer Department, and special advisors on legislative matters and representatives of the Ministries of the Economy and Health 1. The current article aims to contribute to the analysis of the assumptions and topics under study by the working group as indicated in the Ruling, and to propose measures to reduce the illicit trade in tobacco products. On price cuts for cigarettes Price increases on tobacco products, especially promoted by tax increases, are one of the most effective ways to reduce tobacco product consumption, especially among the poor 3,4. A monograph 5 published by the National Cancer Institute of the United States in collaboration with the World Health Organization (WHO), in which studies from various countries were analyzed, concluded that there is a correlation between higher taxes and prices and a reduction in tobacco consumption and prevalence. The monograph concludes that a 10% increase in cigarettes prices Considerations on the impact of tax policy on cigarette sales and consumption in Brazil Considerações acerca do impacto da política de impostos sobre o comércio e o consumo dos cigarros no Brasil Consideraciones sobre el impacto de la política fiscal en la venta y consumo de cigarrillos en Brasil PERSPECTIVAS PERSPECTIVES
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