食品和药品安全外文文献翻译.docx

1、食品和药品安全外文文献翻译食品和药品安全的新兴技术外文翻译2018-2019英文Emerging technologies for food and drug safetyWilliam SlikkerAbstractEmerging 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 regul

2、atory 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

3、Summit on Regulatory Science (GSRS17) in Brasilia, Brazil 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 wa

4、s 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

5、 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 overa

6、rching 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.Keywords：Global coalition，Emerging tec

7、hnologies，Food safety，Drug safety，Regulatory agencies，Alternative methods，Best practices，Cross-trainingIntroductionEmerging technologies for food anddrug safety assessmentrepresent a growth area for regulatory sciences. With the goal of faster, less expensive and more predictive assessment approache

8、s, many new technologies have been proposed. Although 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 Sc

9、ience (GSRS17) was Emerging Technologies for Food and 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 and developing partnerships to enhance translation of

10、basic science into regulatory applications within the global context. The conference provides an interactive platform for scientists from government, industry, and academic-research communities to objectively assess the utility of emerging technologies (such asnanotechnology, imaging,omicsfor transl

11、ational science, precision medicine,bioinformaticapproaches, medical product safety, and food safety) for addressing regulatory research questions and to discuss the best way to translate these technologies into real-world applications. GSRS17 also allowed the opportunity to exchange views and pract

12、ices that can assist the regulatory research community in harmonizing educational and training 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 t

13、he presentations from Brazil, the European Union, Nigeria and Japan, several common questions were addressed by the presenters. These included: 1) What are the common regulatory science issues and practices across governmental agencies? 2) Which infrastructure/mechanism should be developed to addres

14、s these common issues and practices? 3) How do you envision the cross-training opportunities to facilitate knowledge to be exchanged across agencies?Dr. Meiruze Sousa Freitas, Deputy Director,Authorizationand Health Registry, Brazilian Health Surveillance Agency (ANVISA), described that ANVISA has a

15、 hierarchy based on legislation and a competency to edit legislation on health surveillance-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 discus

16、sions based on the technical procedures with international cooperation groups.In ANVISA, regulation is coordinated by two offices: Drug General Management Office (GGMED) and Food General Management Office (GGALI), which are subordinate to the Authorization and Health Registration Directory (DIARE).

17、The GGMED is composed of the Office of Safety and Efficacy Evaluation (GESEF), the Department ofTherapeutic Equivalence(CETER), the Drug Registration Evaluation Office (GRMED), the Office of Specific andHerbal DrugsRegistration Evaluation (GMESP), and the Office of Post-Approval Changes Evaluation (

18、GEPRE). The staff consists of health regulation experts, regulation technicians and administrative personnel including a wide range of professionals, namely, biologists, bio-medics, chemists, doctors, engineers, lawyers, pharmacists, physicians and statisticians. GGMED performs drug registration thr

19、ough evaluation of drugs applications, post-approval change applications and drug registration renewal. Other actions connected are “in situ” inspections of the applications mentioned, implementation of audits on the application review process, inspections on pharmaceutical equivalence and bioequiva

20、lence/bioavailability centers, evaluation of safety and efficacy (clinical trials), and drafting/reviewing legislation. Recent improvements to ANVISAs review process include systematic standardized approaches to the benefit/risk assessment of medicines and moving towards stepwise implementation of G

21、ood Review Practices (GRevP).ANVISAs other major component is the Food General Management Office (GGALI). It encompasses the Risk Assessment and Effectiveness Office (GEARE), the Food Registration Office (GEREG) and the Post-Registration Food Office (GEPRA). The professional team reviewing at GGALI

22、consists of health regulation experts and administrative personnel, including several professionals, such as food engineers, biologists, pharmacists, nutritionists and veterinarians. As an overview of the national food safety control system, the primary production is the responsibility of the agricu

23、ltural agencies, while responsibility for the subsequent stages of production is shared between the health and agriculture agencies. Actions of these agencies are largely co-dependent. In Brazil, food health control is a mixed model. In pre-marketing, assessment involves health promotion, register a

24、nd safety assessment, and food standards.In summary, ANVISA uses best practices and international guidelines to create Brazils standards. Information is frequently obtained by contact with other regulatory and international agencies and communication using existing technical knowledge bases availabl

25、e on various web sites and confidential information exchange with other regulatory authorities.Hans-Georg Eichler, MD, MSc, Senior Medical Officer, European Medicines Agency (EMA), United Kingdom (UK), EU, focused on regulatory science and the evolving role ofpharmacovigilance. Pharmacovigilance ste

26、ms from the 1970s and means “close watch”. It is the practice of monitoring the effects of medical drugs following licensure and market entry, especially to identify and evaluate previously unreported adverse reactions. It is the science and activities related to detection, assessment, understanding

27、 and prevention of adverse effects or any other drug-related problem.Dr. Eichler described some of the difficulties encountered when practicing precision medicine. Often thestratificationcriterion is not completely understood, the numbers of patients are smaller but there are advanced therapies (gen

28、e, cell, tissue-based), and some of them are truly personalized. Personalized treatment combinations are even more complex in that the scientists must deal with small patient numbers and it is sometimes difficult to define clinical indications. Dr. Eichler also highlighted the difference(s) between

29、efficacy and effectiveness in clinical practice. Efficacy is the extent to which an intervention does more good than harm under ideal circumstances (monitoring the patient taking the drug). Effectiveness is the extent to which an intervention does more good than harm when provided under the usual ci

30、rcumstances of health care practice. Accounting forheterogeneitywill lead to more precise precision medicine and a different approach to drug development. Dr. Eichler also mentioned that it is very likely that regulators and the health delivery system will need to shift some health care practices in

31、 the future in case we account for heterogeneity.Dr. Eichler believes that the future evolution of pharmacovigilance will be facilitated by pay-for-performance and pre-licensing of real world data. This will be thepinnacleof individualized pharmacovigilance. There will be a shift from population to

32、patient level, from prediction to observation-based decision-making. Treatment responsive and non-responsive will be identified, and the use of patient-level outcomes would enable outcome-based contracting and, perhaps further improve patient safety and public health by focusing on patient experienc

33、es. Dr. Eichler concluded by emphasizing that the development of pharmacovigilance will likely bring shifts of focus from safety-only to benefits and harms, from pharmacovigilance to knowledge generation, and from population focus to patient-level focus. He also indicated acontinuumknowledge generation spanning the pre- and post-licensi