食品和药品安全外文文献翻译2018-2019Word文件下载.docx

1、Emerging technologies for food and drug safety William SlikkerAbstractEmerging technologies are playing a major role in the generation of new approaches to assess the safety of both foods and drugs. However, theintegrationofemergingtechnologiesintheregulatory decision-making process requires rigorou

2、s assessment and consensus amongst international partners and research communities. To that end, the GlobalCoalitionforRegulatoryScienceResearch（GCRSR）in partnership with the Brazilian Health Surveillance Agency （ANVISA） hosted the seventh Global Summit on Regulatory Science （GSRS17） in Brasilia, Br

3、azil on September 1820, 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

4、 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 add

5、ition, the strengths and16weaknesses 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 r

6、egulators 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.Keywords：Global coalition，Emerging technologies，Food safety，Drug safety，Regulatory agencie

7、s，Alternative methods，Best practices， Cross-trainingIntroductionEmergingtechnologiesforfoodand drugsafety assessment represent a growth area for regulatory sciences. With the goal of faster, less expensive and more predictive assessment approaches, many new technologies have been proposed. Although

8、some of these new assessment approaches have gained considerable attention, few if any have been universally accepted as available to replace existing testing paradigms. With this in mind the focus of the 7th annual Global Summit on Regulatory Science （GSRS17） was Emerging Technologies for Food and

9、Drug Safety. GSRS17 is an international conference held under the auspices of the Global Coalition for Regulatory Science Research （GCRSR）, with the goal of discussing innovative technologies anddeveloping partnerships to enhance translation of basic science into regulatoryapplicationswithinthegloba

10、lcontext.Theconference provides an interactive platform for scientists from government, industry, and academic-research communities to objectively assess the utility of emergingtechnologies（suchas nanotechnology,imaging, omics for translationalscience,precisionmedicine, bioinformatic approaches, med

11、ical product safety, and food safety） for addressing regulatory researchquestions and to discuss the best way to translate these technologies into real-world applications. GSRS17 also allowed the opportunity to exchange views and practices that can assist the regulatory researchcommunityinharmonizin

12、geducationalandtraining opportunities world-wide.Global regulatory landscapeTo compare the status of regulatory science as applied to food and drug safety around the world, the Global Regulatory Landscape was assessed. To focus the presentations from Brazil, the European Union, Nigeria and Japan, se

13、veral common questions were addressed by the presenters. These included: 1） What are the common regulatory science issuesandpracticesacrossgovernmentalagencies?2）Which infrastructure/mechanism should be developed to address these common issuesand practices?3）How do youenvision thecross-training oppo

14、rtunities to facilitate knowledge to be exchanged across agencies?Dr. Meiruze Sousa Freitas, Deputy Director, Authorization and Health Registry, Brazilian Health Surveillance Agency （ANVISA）, described that ANVISA has a hierarchy based on legislation and a competency to edit legislation on health su

15、rveillance-related subjects. ANVISA is very connected to the global community and the Good Regulatory Practices Process. International approaches and information are collected through contact with authorities and discussions based on the technical procedures with international cooperation groups.In

16、ANVISA, regulation is coordinated by two offices: Drug General Management Office （GGMED） and Food General Management Office （GGALI）,which are subordinateto theAuthorization and Health Registration Directory （DIARE）. The GGMED is composed of the Office ofSafetyandEfficacyEvaluation（GESEF）,theDepartment of Therapeutic Equivalence （CET