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  • 文章类型: Journal Article
    强制性营养标签,2003年在马来西亚推出,获得了公共卫生专家的“中等实施”评级,此前我们集团以国际最佳实践为基准。评级促使这项定性案例研究在政策过程中探索障碍和促进者。方法结合了半结构化访谈,并补充了引用的文件以及截至2017年的本地和国际方向的历史映射。案件参与者在联邦政府担任高级职务(n=6),食品工业(n=3)和民间社会代表(n=3)。历史映射显示,国际方向刺激了马来西亚的政策进程,但政策惯性导致了执行差距。阻碍政策进程的障碍包括缺乏资源,治理复杂性,缺乏监控,技术挑战,与成本计算相关的政策特征,在政策宣传方面缺乏持续的努力,实施者特征和/或行业阻力,包括公司政治活动(例如,游说,政策替代)。政策进程的促进者是资源最大化,领导力,利益相关者的伙伴关系或支持,政策窗口和行业参与或支持。逐步执行政策需要更强有力的领导,资源,部际协调,宣传伙伴关系和问责制监测系统。这项研究为国家和全球政策企业家制定促进健康食品环境的战略提供了见解。
    Mandatory nutrition labelling, introduced in Malaysia in 2003, received a \"medium implementation\" rating from public health experts when previously benchmarked against international best practices by our group. The rating prompted this qualitative case study to explore barriers and facilitators during the policy process. Methods incorporated semi-structured interviews supplemented with cited documents and historical mapping of local and international directions up to 2017. Case participants held senior positions in the Federal government (n = 6), food industry (n = 3) and civil society representations (n = 3). Historical mapping revealed that international directions stimulated policy processes in Malaysia but policy inertia caused implementation gaps. Barriers hindering policy processes included lack of resources, governance complexity, lack of monitoring, technical challenges, policy characteristics linked to costing, lack of sustained efforts in policy advocacy, implementer characteristics and/or industry resistance, including corporate political activities (e.g., lobbying, policy substitution). Facilitators to the policy processes were resource maximization, leadership, stakeholder partnerships or support, policy windows and industry engagement or support. Progressing policy implementation required stronger leadership, resources, inter-ministerial coordination, advocacy partnerships and an accountability monitoring system. This study provides insights for national and global policy entrepreneurs when formulating strategies towards fostering healthy food environments.
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  • 文章类型: Journal Article
    Nutrition and health claims should be truthful and not misleading. We aimed to determine the use of nutrition and health claims in packaged foods sold in Mongolia and examine their credibility. A cross-sectional study examined the label information of 1723 products sold in marketplaces in Ulaanbaatar, Mongolia. The claim data were analysed descriptively. In the absence of national regulations, the credibility of the nutrition claims was examined by using the Codex Alimentarius guidelines, while the credibility of the health claims was assessed by using the European Union (EU) Regulations (EC) No 1924/2006. Nutritional quality of products bearing claims was determined by nutrient profiling. Approximately 10% (n = 175) of products carried at least one health claim and 9% (n = 149) carried nutrition claims. The credibility of nutrition and health claims was very low. One-third of nutrition claims (33.7%, n = 97) were deemed credible, by having complete and accurate information on the content of the claimed nutrient/s. Only a few claims would be permitted in the EU countries by complying with the EU regulations. Approximately half of the products with nutrition claims and 40% of products with health claims were classified as less healthy products. The majority of nutrition and health claims on food products sold in Mongolia were judged as non-credible, and many of these claims were on unhealthy products. Rigorous and clear regulations are needed to prevent negative impacts of claims on food choices and consumption, and nutrition transition in Mongolia.
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  • 文章类型: Journal Article
    Pharmaceutical labeling describes the safe and effective use of an approved product. Such information may be provided to consumers and/or health care physicians, and available online or in the pack in a variety of different formats according to local or regional regulations. Depending on the Health Authority (HA), content within a nationally approved label is generally reliant on two primary sources, a Company Core Data Sheet (CCDS), and the text approved by the Health Authority. Content in the nationally approved label may differ from the CCDS for a variety of reasons. In some countries, HAs require the Marketing Authorization Holder (MAH) to base their national label on an already approved label in a \"major market\" economy, only approving changes to the label when there is evidence that the major market has already approved. In this paper, we examine recent steps taken by the Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) to change labeling regulation in Japan in the context of the recently communicated national strategy, and assess whether this may impact on uptake of the J-PI as a reference label. Decreases in approval times by PMDA for new products, development of basic principles on multiregional clinical trials, greater transparency of content on the PMDA website, and increasing outreach to other Asian Agencies in recent years are highlighted. Labeling harmonization across regions, particularly of safety-related information, represents a key factor in promoting patient safety and risk communication, and is a worthy topic for future ICH consideration.
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