'If I hadn't seen this picture, I'd be smoking'-perceptions about innovations in health warnings for cigarette packages in Brazil: a focus group study.

OBJECTIVE: To 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. METHODS: Twenty 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. RESULTS: Health 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. CONCLUSION: Introducing 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.

Health without filters: the health and environmental impacts of cigarette filters. / Saúde sem filtro: os impactos dos filtros dos cigarros na saúde e no meio ambiente.

Tobacco-related diseases kill eight million people worldwide ever year and are responsible for thousands of cases of cancer, cardiovascular disease and other illnesses in Brazil. Cigarette filters are believed by many to reduce the health risks of smoking. This article outlines the history of the technology of filters and discusses the impacts of these cigarette design features and their regulation. We conducted a literature review to assess the impacts of this technology. The results show that filters were initially developed for aesthetic purposes and later improved and marketed as a harm reduction technology. The most widely-used filters are those made of cellulose acetate with or without activated carbon. Despite smokers' beliefs and advertising claims, filters have no health benefits and filter tip ventilation can increase the health risks of smoking. Filters can also make cigarettes more appealing and cause significant environmental impacts. Cigarette filters have no health benefits and lull smokers into a false sense of security and should therefore be banned.

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.

Saúde sem filtro: os impactos dos filtros dos cigarros na saúde e no meio ambiente / Health without filters: the health and environmental impacts of cigarette filters

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.

Abstract Tobacco-related diseases kill eight million people worldwide ever year and are responsible for thousands of cases of cancer, cardiovascular disease and other illnesses in Brazil. Cigarette filters are believed by many to reduce the health risks of smoking. This article outlines the history of the technology of filters and discusses the impacts of these cigarette design features and their regulation. We conducted a literature review to assess the impacts of this technology. The results show that filters were initially developed for aesthetic purposes and later improved and marketed as a harm reduction technology. The most widely-used filters are those made of cellulose acetate with or without activated carbon. Despite smokers' beliefs and advertising claims, filters have no health benefits and filter tip ventilation can increase the health risks of smoking. Filters can also make cigarettes more appealing and cause significant environmental impacts. Cigarette filters have no health benefits and lull smokers into a false sense of security and should therefore be banned.

Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA).

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.

Eficiência regulatória: análise de sobrevivência aplicada à trajetória de registro de medicamentos genéricos / Texto para Discussão (TD) 1774: Eficiência regulatória: análise de sobrevivência aplicada a trajetória de registro de medicamentos genéricos

Ao longo dos últimos anos, um novo e desafiante cenário no registro de medicamentos genéricos vem sendo gradativamente incorporado na rotina de análise dos dossiês de registro apresentados à Agência Nacional de vigilância Sanitária (Anvisa) pela indústria farmacêutica, no Brasil. Este trabalho calcula os prazos para obtenção de registro de medicamentos genéricos e os principais pontos envolvidos no ganho ou na perda de eficiência neste processo. Apresenta os conceitos atuais incorporados na regulação dos medicamentos genéricos, tais como genéricos inéditos, medicamentos priorizados e medicamentos clones.