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新修订的《药品注册管理办法》已于2005年5月1日开始施行,为使大家正确理解和把握《药品注册管理办法》的实质和内涵,在药品研究、生产和申报过程中少走弯路,确保全省药品注册工作高效、规范、有序地进行,就如何学习、贯彻好《品注册管理办法》谈几个方面的问题. 相似文献
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《中国医药技术与市场》2004,4(3):9-10
药品注册现场考察是指药品注册过程中药品监督管理部门对研究、试制样品单位的研制条件和相关记录进行现场检查、抽取样品的过程。《药品注册管理办法(试行)》明确规定,对申请新药临床研究、生产、已有国家药品标准品种的生产及部分补充申请,省、自治区、直辖市药品监督管理局必须进行现场考察。 相似文献
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《药品注册管理办法》第七条规定药品注册申请包括新药申请、已有国家标准的药品申请、进口药品申请和补充申请。已有国家标准的药品申请占注册比例大,质量标准执行情况也比较复杂。本文就注册检验工作中遇到的一些问题,谈谈自己的看法和建议。 相似文献
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自从我国于2001年11月加入世贸组织,特别是2002年12月1日《药品注册管理办法》(试行)施行以来,我国医药行业尤其是医药企业从事管理和技术开发人员的专利保护意识有了很大的提高,与药品相关的专利申请数量也相应地出现了较快的增长。然而,由于多数人已经习惯于按多年来形成的新药注册的思路办事,没有注意到专利申请过程中的某些区别,从而难以实现思路的转换,在一定程度上影响了专利申请的顺利进行。现简要介绍一些专利申请与新药注册的异同,供医药工作者申请专利时参考。 相似文献
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近年来,随着国内多起假药劣药伤人事件的发生,特别是近期包括原国家食品药品监督管理局局长郑筱萸在内的多位药监局高层领导相继下马,药品安全问题更加引起全社会的广泛关注,药品安全问题也自然成为了今年两会上代表和委员热议的话题。两会代表和委员认为我国现行《药品注册管理办法》存在的漏洞是导致药品管理官员违法、违纪,而造成大量“新药”上市的重要原因。因此,代表委员多次呼吁宜尽快修改《药品注册管理办法》。国家食品药品监管局近日已经对新修订后的《药品注册管理办法(征求意见稿)》在官方网站进行为期两个月的公示, 相似文献
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儿科临床研究与儿童用药安全 总被引:5,自引:1,他引:4
通过分析我国儿童用药现状,介绍国外儿科药品研究进展,指出我国应积极学习和借鉴国外先进经验,尽早制订出符合我国国情的儿童药品研究政策,进而指导儿科医师合理、安全用药。 相似文献
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Andrew T. Weil 《Journal of psychoactive drugs》2013,45(4):335-337
ABSTRACTSupport for legalization of marijuana has increased over the past several years. While studies have examined correlates of favoring marijuana legalization, less attention has been placed on those who are unsure about legalization, despite the potentially important role of this group as states vote on legalization in upcoming elections. Using data from a statewide sample of adults in Michigan, this study examined whether those who support, oppose, or are unsure about legalization differed based on demographics, marijuana use, and perceived risk associated with marijuana use. Those who were older and perceived marijuana use to pose a greater risk had lower odds of being unsure about legalization (relative to opposing legalization); those who were politically left of center or centrist and those who reported lifetime marijuana use had higher odds of being unsure about legalization. Older respondents, women, and those who perceived marijuana use to be risky had lower odds of supporting legalization; those who were politically left of center or centrist, and those who reported recent or lifetime marijuana use had higher odds of supporting legalization. Better understanding correlates of being unsure about marijuana legalization may help inform political and prevention efforts as states continue to vote on these issues. 相似文献
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Cambrey Nguyen 《The Journal of pharmacy technology》2021,37(3):161
Pharmacists use a myriad of drug resources for patient care; however, the drug manufacturer is often overlooked and underutilized as a resource for drug information. Pharmaceutical companies have a medical information department that is responsible for providing drug information to pharmacists and the public about the company’s products. This article will explain the purpose and functions of the medical information department within a pharmaceutical company. In addition, the type of information that may be requested and the ways to request drug information will be discussed. 相似文献
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关于药物创新与药品管理关系的思考 总被引:1,自引:0,他引:1
在建设创新型国家的主旋律下,每一种角度的论述都给予药物创新神圣的使命,使得药物创新具有越来越高的势能,但同时,我们距离药物创新的客观规律和现实性似乎有了越来越高深的鸿沟,药物创新也越来越缺乏具有中国特色的可操作性。 相似文献
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随着医药经济的飞速发展和药品监管任务的日益繁重,现行药品抽验运行机制与“经济必要、突出重点、分工合理、追踪问效”的抽样原则不相适应的矛盾越来越突出地显现在我们面前,并将继续困扰我们。2004年6月,国家食品药品监督管理局局长郑筱萸在全国食品药品监督管理工作座谈会上指出,要以科学发展观统揽食品药品监管工作全局,要整合监管资源,增强监管合力,提高监管效率。这为我们客观正视、深入研究并着力解决这一矛盾指明了方向。 相似文献
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Abstract The use of crack cocaine and its associations with high-risk sexual behavior in view of the AIDS epidemic is reported commonly for major East and West Coast urban centers. This article describes and analyzes ethnographic data on crack use in Dayton, Ohio, a small midwestern city of less than 200,000 people. The results of 15 tape-recorded interviews are employed to sketch the basic outlines of crack use among African Americans. A major focus is placed on analyzing the characteristics of the exchange of crack for sexual favors. High-risk behaviors for the transmission of HIV and other sexually transmitted diseases are explored. 相似文献
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Gavrilov A. S. Ilyukhina R. V. Isaeva I. V. Lyublinskaya L. A. 《Pharmaceutical Chemistry Journal》2001,35(7):400-403
Pharmaceutical Chemistry Journal - 相似文献
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