Regulatory landscape of dietary supplements and herbal medicines from a global perspective

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emerging technologies for food and drug safety

Abstract Emerging technologies are playing a major role in the generation of new approaches to assess the safety of both foods and drugs. However, the integration of emerging technologies in the regulatory decision-making process requires rigorous assessment and consensus amongst international partners and research communities. To that end, the Global Coalition for Regulatory Science Research (GCRSR) in partnership with the Brazilian Health Surveillance Agency (ANVISA) hosted the seventh Global Summit on Regulatory Science (GSRS17) in Brasilia, Brazil on September 18–20, 2017 to discuss the role of new approaches in regulatory science with a specific emphasis on applications in food and medical product safety. The global regulatory landscape concerning the application of new technologies was assessed in several countries worldwide. Challenges and issues were discussed in the context of developing an international consensus for objective criteria in the development, application and review of emerging technologies. The need for advanced approaches to allow for faster, less expensive and more predictive methodologies was elaborated. In addition, the strengths and weaknesses of each new approach was discussed. And finally, the need for standards and reproducible approaches was reviewed to enhance the application of the emerging technologies to improve food and drug safety. The overarching goal of GSRS17 was to provide a venue where regulators and researchers meet to develop collaborations addressing the most pressing scientific challenges and facilitate the adoption of novel technical innovations to advance the field of regulatory science

Emerging technologies and their impact on regulatory science

There is an evolution and increasing need for the utilization of emerging cellular, molecular and in silico technologies and novel approaches for safety assessment of food, drugs, and personal care products. Convergence of these emerging technologies is also enabling rapid advances and approaches that may impact regulatory decisions and approvals. Although the development of emerging technologies may allow rapid advances in regulatory decision making, there is concern that these new technologies have not been thoroughly evaluated to determine if they are ready for regulatory application, singularly or in combinations. The magnitude of these combined technical advances may outpace the ability to assess fit for purpose and to allow routine application of these new methods for regulatory purposes. There is a need to develop strategies to evaluate the new technologies to determine which ones are ready for regulatory use. The opportunity to apply these potentially faster, more accurate, and cost-effective approaches remains an important goal to facilitate their incorporation into regulatory use. However, without a clear strategy to evaluate emerging technologies rapidly and appropriately, the value of these efforts may go unrecognized or may take longer. It is important for the regulatory science field to keep up with the research in these technically advanced areas and to understand the science behind these new approaches. The regulatory field must understand the critical quality attributes of these novel approaches and learn from each other's experience so that workforces can be trained to prepare for emerging global regulatory challenges. Moreover, it is essential that the regulatory community must work with the technology developers to harness collective capabilities towards developing a strategy for evaluation of these new and novel assessment tools

High hydrostatic pressure treatment for the assessment of quality in sliced skin-packaged cooked and cured hams

In this study, a pressure of 600 Mpa was applied to sliced skin-packaged cooked ham and cured hams. Different lots were spiked with different food pathogens and spoiling microorganisms: slime-producing lactic acid bacteria (LAB), Staphylococcus aureus, Listeria monocytogenes, Yersinia enterocolitica, Escherichia coli, Salmonella spp., Campylobacter jejuni and Debaryomyces hansenii and compared to non-spiked samples. All samples were treated at high pressures and compared to parallel treatments non pressurized. Samples were stored up to 120 days at 4C and periodically analyzed.</p

Tipología de pequeñas y medianas industrias productoras de embutidos curados de cataluña

El presente trabajo tiene como objetivo analizar la tipología de los “productores tradicionales” y la elaboración de un perfil de los fabricantes catalanes, desarrollado en el marco de un proyecto europeo para evaluar y mejorar la seguridad de los embutidos tradicionales sur-europeos mediante un estricto seguimiento desde el productor hasta el consumidor, preservando la tipicidad de cada producto.Fil: Fadda, Silvina G.. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Tucumán. Centro de Referencia para Lactobacilos; Argentina. Instituto de Investigación y Tecnología Agroalimentarias. Centro de Tecnología de la Carne; EspañaFil: Aymerich, Teresa. Instituto de Investigación y Tecnología Agroalimentarias. Centro de Tecnología de la Carne; EspañaFil: Hugas, Marta. Instituto de Investigación y Tecnología Agroalimentarias. Centro de Tecnología de la Carne; EspañaFil: Garriga, Margarita. Instituto de Investigación y Tecnología Agroalimentarias. Centro de Tecnología de la Carne; Españ