食品药品监管数据中心建设和数据 资源管理现状浅析与建议

随着互联网和信息技术的不断发展,数据资源日益积累,数据的价值和数据管理的重要性随之突显。数据中心作为数据管理和应用的主要部门和载体,也受到越到越多的关注。本文通过对食品药品监管系统内部的数据中心规划、建设现状和数据中心数据资源建设、部署和管理现状进行浅析,研究探讨如何优化食品药品监管数据中心整体功能、强化食品药品监管数据整合管理、促进食品药品监管数据分析利用,以期能够为相关工作提供参考。     

Toxicology at the Food and Drug Administration: new century, new challenges

Dr. Schwetz is the Acting Deputy Commissioner of the Food and Drug Administration (FDA). He was Director of FDA National Center for Toxicological Research in Jefferson, AR, from 1993 to 1999. A diplomate of the American Board of Toxicology, Dr. Schwetz was acting Director of the Environmental Toxicology Program at the National Institutes of Health National Institute of Environmental Health Sciences (NIEHS) in Research Triangle Park, NC, before coming to the FDA in 1993. He was also Associate Director of the National Toxicology program there. He had been Chief of the Institute Systems Toxicity Branch since 1982. Dr. Schwetz currently serves as Adjunct Professor, Department of Pharmacology and Toxicology/Division of Interdisciplinary Toxicology, at the University of Arkansas for Medical Sciences. He was editor of Fundamental and Applied Toxicology from 1986 to 1992, and serves on the Editorial Advisory Board of Environmental Health Perspectives and Critical Reviews in Toxicology. Dr. Schwetz is an invited member of the Canada Health Protection Branch Science Advisory Board, and an elected member of the National Academy of Sciences Institute of Medicine. He is a member of the Society of Toxicology (SOT) and the National Capitol Area Chapter, SOT; the American Veterinary Medical Association; National Society of Phi Zeta, Honor Society of Veterinary Medicine; Teratology Society; Behavioral Teratology Society; and the Reproductive Toxicology Specialty Section of the SOT. He is past president of the Reproductive Toxicology Specialty Section of the SOT and of the North Carolina and the South Central Chapters of the SOT. In addition to numerous other professional awards during his career, Dr. Schwetz received the U.S. Government 1998 Meritorious Executive Presidential Rank Award.     

Biomarker qualification pilot process at the US Food and Drug Administration

New biomarkers of safety and efficacy are becoming powerful tools in drug development. Their application can be accelerated if a consensus can be reached about their qualification for regulatory applications. This consensus requires a review structure within the US Food and Drug Administration (FDA) that can evaluate qualification data for these biomarkers and determine whether these biomarkers can be qualified. A pilot process and corresponding Biomarker Qualification Review Team have been developed to test how the FDA can work on biomarker qualification.     

Clinical pharmacology training at the Food & Drug Administration.

Challenged with the clearly demonstrated need for highly trained clinical pharmacologists for new drug development and review activities, the FDA Center for Drug Evaluation and Research (CDER) established an internal Staff College. This organizationally unique and innovative unit addressed the educational needs of both the new and the veteran CDER scientists. A multileveled strategy was conceptualized and implemented as described.     

2018年美国食品药品监督管理局批准的新药

<正>2018年美国食品药品监督管理局(Food and Drug Administration, FDA)共批准了43个新分子实体(new molecular entity,NMEs)和23个新生物制剂(biologic license applications,BLAs),该数字较2017年的56个,增加了10个(17. 9%)。按照药物作用分类,抗肿瘤药物18个(27. 3%),心血管系统药物12个(18. 2%),呼吸系统药物2个(3.0%),神经系统用药8个(12. 1%),内分泌用药9个(13.6%),抗感染药9个(13.6%),其他药物7个(10. 6%)。     

浅谈食品药品监管部门如何准确把握食品安全监管职能定位

食品安全监管是一项复杂的系统工程，涉及到多个职能部门，国务院赋予食品药品监管部门的职能是：综合监督，组织协调，依法组织开展对重大事故的查处。如何正确理解、准确履行好这一职能，努力把加强党的执政能力建设的总体要求落实到全面提高食品药品监管系统的科学行政、民主行政、依法行政水平上来，建立统一、高效、权威的食品安全监管机制，是摆在每一位食品药品监管工作者面前的重要课题。笔者就此谈谈自己的肤浅看法，旨在抛砖引玉。     

对我州食品药品监管体制改革的思考

目的探讨基层食品药品监管体制改革模式与方案,为全州食品药品安全监管体制改革提供科学依据。方法采用召开座谈会、发放调查问卷、实地走访企业等调研方法 ,分析全州餐饮消费环节食品安全、保健食品、化妆品监管现状。结果建立权威高效的食品药品监管体制、科学设置食品药品监管机构、整合优化食品药品监管队伍,是推进我州食品药品监管体制改革的重要举措。结论构建统一、独立、高效的食品药品安全监管体制,强化食品药品监管,提高监管效能,是保障公众饮食用药安全的需要。     

美国食品安全法制建设对我国的启示

加强食品安全法制建设是当前世界各国都关注的问题之一,也是解决食品安全问题的重要保障.本文对美国的食品安全法律进行了研究,分析评价了它的内容和优势,对我国食品安全法制建设有借鉴意义.     

美国FDA哨点行动及其对我国食品药品监管数据管理的启示

目的：介绍美国FDA哨点行动背景、项目、内容、特点,为我国食品药品监管数据共享利用和管理提供参考。方法：使用文献研究的方法,围绕美国食品药品管理局哨点行动计划收集材料并梳理分析。结果与结论：信息化和大数据时代背景下数据资源共享与食品药品监管业务工作密不可分;顶层支持有助于数据协同共享等工作开展;分布式数据管理模式值得借鉴;产学研结合有助于开展数据分析挖掘;相关方广泛参与有助于从源头保障数据质量。     

Non-US Clinical Trial Data and the Food and Drug Administration

Abstract

Commercial requirements and the use of indigenous science for advertising purposes indicate that at least some studies will always be done in each country where medications are marketed. However, drug development is a transnational phenomenon where data from one country will be used to obtain marketing approval in another. Yet local regulatory and scientific requirements preclude the use of one set of data for all countries, which increases the cost of an already expensive process. In the US the FDA has historically expressed concerns about accepting foreign data as the sole basis for approval of an NDA. Despite the timolol case, foreign data are still used infrequently and only on an ad hoc basis. Data quality, verification, authentication, and inspection continue to be the most important problems in this area. Standardized protocols, and strict adherence to them; the use of investigators with a proven track record, ability, and appropriate training; frequent monitoring by United States drug sponsors; appropriate statistical analyses; a rigorous internal critique of the study; the use of anthropologists to deal with perceived and cryptic cross-cultural problems; and avoidance of “found” data will ameliorate problems with non-US data.     

我国食品药品稽查机构管理模式研究

目的为我国食品药品稽查机构管理模式建设提供理论依据和决策参考。方法对我国食品药品稽查机构的机构设置、职能定位、人员管理等情况进行全面调查,深入分析存在的问题及其成因,提出与经济社会发展相适应的食品药品稽查机构管理模式的对策和建议。结果与结论应建立全国职能上下统一的食品药品稽查机构,科学配置食品药品稽查队伍。     

Fluoroquinolones: A hot topic for pharmacists and the Food and Drug Administration’s Division of Drug Information

Objectives

The Division of Drug Information (DDI) within the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research receives telephone calls, e-mails, and letters from patients and industry. The consistently high number of contacts about drugs in the fluoroquinolone class indicates an opportunity to increase awareness about the drugs’ evolving safety profile.

住院药房药品调剂与药品管理工作体会

目的 总结住院药房药品调剂与药品管理工作的体会,以对住院药房进行规范化管理.方法 探讨住院药房药品调剂工作及药.管理工作的经验及存在的问题,提出防范对策.结果 药品调剂工作易出差错,应提高药师专业素质,增强责任心和使命感,改善工质量.结论 应加强住院药房药品管理工作,避免调剂差错,保证患者用药安全、有效.