征订启事

全面解析监管法规深入探索监管规律广泛交流监管经验及时聚焦社会热点密切关注业界动态准确普及科学知识《中国食品药品监管》杂志是国家食品药品监督管理局的机关刊物,由国家食品药品监督管理局主管,中国医药报社主办。本刊自2011年1月起全面改版     

Food and Drug Administration proposed testing guidelines for reproduction studies. Revision Committee. FDA Guidelines for Developmental Toxicity and Reproduction, Food and Drug Administration.

In the United States, the Food and Drug Administration (FDA) is the agency responsible for ensuring that the direct food additives and color additives used in food are safe for all consumers. In order to determine the safety of these additives for consumption, appropriate information and results from a series of tests must be made available to the agency. In 1982, in an effort to provide guidance to the food industry concerning the appropriate tests for the determination of safety, the FDA issued the Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Foods, commonly referred to as the Redbook. In 1993, based on the expansion of technology and the use of food additives, as well as the refinement of the scientific criteria for establishing safety, the FDA updated its guidelines and issued the draft Redbook II. Since Redbook II was issued, additional refinements have been made in the procedures for the multigeneration reproduction study and for the assessment of effects on male reproduction. The latest proposed guidelines for multigeneration studies are provided here.     

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%)。     

Food and Drug Administration proposed testing guidelines for developmental toxicity studies. Revision Committee. FDA Guidelines for Developmental Toxicity and Reproduction, Food and Drug Administration.

The Food and Drug Administration (FDA) is the agency responsible for ensuring that the direct food additives and color additives used in food in the United States are safe for all consumers. In 1982, in an effort to provide guidance concerning appropriate tests, the FDA issued Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food, commonly known as the Redbook. The Redbook included detailed guidelines for testing the effects of direct and indirect food and color additives on mothers and their developing fetuses. Based on refinements in safety assessment and risk evaluation as well as expansion of knowledge concerning the metabolism and pharmacokinetics of food and color additives, the need to revise and update the 1982 document became apparent. In 1993, Redbook II in draft form was made available for public comment. Since then, test end points and developmental landmarks have been refined. The latest proposed guidelines for developmental toxicity studies are provided here.     

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。     

关于安徽省食品药品监督管理系统社会招考公务员的几点思考

近年来，安徽食品药品监管系统针对新组建人员知识、专业及年龄结构不够合理的实际情况，连续4年面向社会公开招考公务员，有力地推进了干部队伍科学化、年轻化和专业化建设。但是，随着食品药品监管形势和任务的不断变化，对招录公务员工作的要求也在不断提高，现行招考方式还有待改进。     

Food and Drug Administration monitoring of adverse drug reactions

Food and Drug Administration requirements for reporting adverse drug reactions (ADRs), processing of ADR reports, and actions in response to these reports are described. FDA requires that drug manufacturers report ADRs to the FDA Division of Epidemiology and Surveillance; 90% of the ADR reports received are from manufacturers. Of the remaining 10%, one third are from pharmacists. FDA regulations were revised in 1985 to specifically define reportable ADRs and procedures for reporting; manufacturers are required to report within 15 days reactions that are serious and unlabeled. For newly approved drugs, reports on ADRs must be submitted quarterly for three years; subsequently, annual reporting is required. Any increase in the frequency of serious, labeled reactions must be reported. Serious reactions not listed in the product labeling must be reported for products marketed before 1962 for which new drug applications or abbreviated new drug applications were not filed. ADR information received by FDA is coded into standard terms and entered in a computerized database for evaluation by reviewers. If an important reaction is suspected, the report is entered in a tracking system for further monitoring. ADR reports may result in requirements for changes in product labeling, "Dear Doctor" letters, requirement of further study by the manufacturer, or withdrawal of the product. Information about ADRs is communicated to health-care practitioners in product labeling and in the literature. Pharmacists are encouraged to report suspected serious and unlabeled reactions to FDA so that the medical community and the public can benefit from current information about drug safety.     

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.     

The Food and Drug Administration algorithm. Special workshop--regulatory

The Food and Drug Administration presently receives and evaluates over 40,000 case reports of adverse drug effects a year. Each report is objectively reviewed and evaluated. A causal association assessment between each drug and reaction is made. The objective causal assessments are based on four basic principles: (a) temporal eligibility, (b) dechallenge and outcome, (c) rechallenge and outcome, and (d) confounding factors. This presentation introduces the algorithm used by the FDA Division of Drug Experience and provides the basic information needed to use the FDA algorithm for making causal relationship assessments.     

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。     

上海市食品药品监管局积极推进政府信息公开

上海市食品药品监管局积极推进政府信息公开工作,逐步将管理相对人和广大市民最为关注的有关食品药品的监管信息向社会公开。目前,由上海市食品药品监管局编制了《政府信息公开目录》框架和《政府信息公开指南》。第一批2 62条主动公开信息已在局政务网对外发布,内容包括机构职能、政务公开及办事指南、数据库、规范性文件、通知(包括招聘通知)等。其它信息待整理后逐步纳入《政府信息公开目录》,以便公众查询。上海市食品药品监管局《政府信息公开目录》框架包括机构职能、政策法规、规划计划、业务等5个大类。其中机构职能中包括机构概况…     

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。     

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.