关于申报"改变国内药品生产企业名称"补充申请时需要注意的几个问题

药品生产企业变更企业名称的，首先应向工商行政管理部门提出申请；核准变更后，根据《药品生产监督管理办法》的规定，向原发证机关申请《药品生产许可证》变更登记；获得批准后，再根据《药品注册管理办法》的要求，向省级药品监督管理部门递交“改变国内药品生产企业名称”的补充申请，符合规定的，发给《药品补充申请批件》，并报送国家食品药品监督管理局备案，不符合规定的，发给《审批意见通知件》，并说明理由。笔者对申报单位在报送“改变国内药品生产企业名称”补充申请时经常咨询和容易出现的问题进行了整理和分析，仅供参考。     

湖北加强仿制药品审批管理

最近,湖北省卫生厅对仿制药品的审批发出《补充通知》,指出: 申请仿制药品的企业必须是取得《药品生产企业许可证》的企业,并有与所申请     

《药品注册管理办法(征求意见稿)》 主要修订内容简介

《药品注册管理办法(征求意见稿)》(简称修订稿)与现行《药品注册管理办法》(简称现行版)相比,在总则、临床试验、进口药品的申报与审批、非处方药的注册、药品的补充申请与审批、药品注册     

关于补充申请程序中国家标准修订工作适用性的探讨

根据现行《药品注册管理办法》的有关规定，药品标准修订申请按补充申请程序及要求申报。药品标准的修订按标准类型可分为试行标准的修订和国家药品标准的修订。所有修订按注册管理办法规定都须按相应的程序申报（增加程序内容），资料要求一致，审批时限相同。然而，不同的标准类型所对应的特点不同，按同一审批程序管理，存在很大的问题，在实际工作中面临很多困惑。下面就存在的问题进行分类分析。     

国家食品药品监督管理局发布进口药品再注册有关事项公告

根据《药品注册管理办法》的有关规定,近日,国家食品药品监督管理局发出公告,对进口药品再注册和分包装申报、受理、审批,再注册核档程序、再注册期间临时进口和分包装、再注册涉及的补充申请,再注册和补充申请注册证编发等有关事项,作出进一步规范。     

2014至2016年安徽省药品注册现状分析

目的：总结安徽省2014至2016年药品注册情况,为本省的药品研发、申报、审批提供参考。方法：通过梳理药品企业在2014至2106年新药、仿制药、补充申请和再注册申请的情况,对安徽省药品注册申请进行统计分析与评价。结果：近3年,安徽省药品注册申请数量主要集中在药品再注册和补充申请。新药申请中,97%的药品申报临床试验,化学药品占新药申请的90%。仿制药申报品种均为化学药品。结论：安徽省药品注册申报类别分布合理,在生物制品的新药研发上取得进步,中药研发方面有待加强。     

某院临床急需进口药品申请问题分析与建议——乐城先行区急需进口药品助力真实世界研究

本论文通过分析临床急需进口药品当前在上海交通大学医学院附属瑞金医院海南医院申请及审批环节的现状,探讨临床急需进口药品资料在申请审批环节中存在的问题。研究发现,在临床急需进口药品的首次申请中,审批无驳回的申请耗费时间会大大缩短。通过分析临床急需进口药品申请资料,发现其中主要问题为基本资料信息缺失、不全,信息不一致等,建议加强业务培训,提高申请资料质量,加强沟通,提高审批效率,从而达到缩短药品审批环节的消耗时长,加快国际创新临床药品落地乐城先行区。     

药品补充申请表的填写要求及问题说明

《药品补充申请表》是申请人提出药品补充申请的基本文件,同时也是药监部门对该申请进行审批的依据,是省级药品监督管理部门(以下简称省局)对药品补充申请进行形式审查的重点,其填写必须准确、规范,并符合填表说明的要求。现将补充申请表填写中出现的一些常见问题总结如下,以便于正确、规范地填写补充申请表。补充申请表第1项注册事项分类填写不当。补充申请事项既包括报国家食品药品监督管理局(SFDA)批准事项(《办法》附件四1-18项)又包括报SFD A备案事项(《办法》附件四19-28项),两者需分开申报。一份表中可以同时填报多项由同一技术…     

山东省药品再注册审查审批工作全面启动

根据国家食品药品监督管理局《关于做好药品再注册审查审批工作的通知》要求,山东省药品再注册审查审批已全面启动。按照全省药品再注册工作会议部署和要求,药品生产企业已陆续补充完善相关资料,省局遵循“依据法规、严格程序、严格标准;具体问题的处理上坚持尊重历史、尊重事实、尊重证据”的原则,确保我省近8000个药品再注册申请于2010年9月30日前顺利完成。     

日本的药物审批和开发

日本的药物审批和开发杨燕军（广东省药物研究所广州５１０１８０）在日本，药品的销售额仅次于美国［１］，因此，美国及欧共体成员国致力于日本药物审批过程的研究，希望打入日本药品市场。本文就日本药品审批程序及药物开发作一介绍。一、审批过程日本的新药申请须首先...     

Defending girlfriends, buddies and oneself: injunctive norms and male barroom aggression

Objective

Research has demonstrated that young adults tend to overestimate their peers' approval of risky behaviors (i.e., injunctive norms) and that perceived peer approval is associated with actual behavior; however, no empirical studies have assessed injunctive norms in relation to male barroom aggression. The objectives of the present study were to compare young men's own approval of male barroom aggression with their perceptions of approval by male and female peers and to determine the extent that perceived peer approval of male barroom aggression was associated with self-reported physical aggression at a bar, controlling for own approval and heavy episodic drinking.

Method

525 young adult male university and community college students who reported drinking and going to a bar, club or pub rated their own approval and perceptions of peers' approval of bar aggression on items reflecting four domains of approval: (1) general approval, (2) defend self, (3) defend friend and (4) protect girlfriend.

Results

For all four domains, participants attributed greater approval to male peers than to themselves. Aggression was positively associated with own approval for all domains and with perceived male peer approval for general approval, defend self and defend friend, controlling for heavy episodic drinking and own approval of aggression. Perceived approval by female peers was not associated with increased likelihood of aggression.

Conclusion

The findings suggest that both perceived male peer approval and personal approval are factors associated with male barroom aggression and that addressing approval of barroom aggression is a critical direction for prevention programming.     

A comparison of regulatory approval times for new chemical entities in Australia, Canada, Sweden, the United Kingdom, and the United States.

Regulatory approval times of new chemical entities (NCEs) in Australia, Canada, Sweden, the United Kingdom (UK), and the United States (US) were compared. The approval times of a set of common 25 NCEs and a larger set of unmatched NCEs were very similar in Australia, Canada, Sweden and the US, with median approval times from 23 to 29 months. The median approval time in the UK was approximately 11 months. Analysis of the data showed that the approval times in Australia, Sweden, and the UK were not significantly affected by the therapeutic classification of the drug, the amount of additional data requested and received, or the submission date. In Canada, the date the drug submission was received and the frequency of additional data requests significantly affected the approval times. In the US, the date the drug submission was received and the frequency of additional data received significantly affected the approval times. The therapeutic classification of the drug did not significantly affect the approval time in Canada or the US.     

Comparing injunctive marijuana use norms of salient reference groups among college student marijuana users and nonusers

Marijuana is the most commonly used illicit drug among college students and has the potential for various negative outcomes. Perceptions of what constitutes typical approval/acceptability of a reference group (i.e. injunctive social norms) have been shown to have strong utility as predictors of health-risk behaviors in the college context, yet this construct remains significantly understudied for marijuana use despite its potential for use in social norms-based interventions. The current research evaluated individuals' marijuana approval level and their perceptions of others' marijuana approval level (i.e. injunctive norms) for various reference groups (typical student on campus, one's close friends, and one's parents) as a function of individual user status (abstainers, experimenters, occasional users, and regular users). A diverse sample of 3553 college students from two universities completed an online survey. Among all user status groups, individual approval yielded mean scores paralleling that of perceived close friends' approval and all groups were relatively uniform in their perception of typical students' approval. Higher levels of marijuana use tended to produce higher endorsements of individual approval, perceived close friends' approval, and perceived parental approval. Among occasional and regular users, there were no differences between one's own approval level for use and the perceptions of close friends' approval, nor did they think the typical student was more approving than themselves. Abstainers and experimenters, however, perceived typical students and close friends to have more permissive attitudes than themselves. Implications and future directions for research regarding the role of injunctive marijuana use norms in the development of social norms intervention are discussed.     

电子政务背景下我国药店审批状况分析

在查阅32省、直辖市、自治区政府网站的基础上,分别对各个城市的药店审批名称、审批依据、审批条件、审批步骤、审批费用等状况进行了分析和对比,归纳出全国药店审批状况的特点,并对存在的问题进行了剖析,从而提出审批名称统一、审批依据统一、审批条件告知、审批程序完善等相关建议。     

集中行政许可权改革模式下药品经营许可审批现状分析

目的 为优化集中行政许可权改革模式下药品经营许可证的审批流程提供参考.方法 通过总结药品经营许可业务由药品监管部门划转至行政审批部门的改革成效及不足,提出优化药品经营许可证办理的改革方向建议.结果 业务划转后,取得了一定的改革成效,规范了审批程序,加强了审批过程中相关专业的知识储备,节省了公共资源;但存在行政许可标准与...     

Pharmacy practice research,ethical issues and local research ethics committees

Pharmacy practice research projects carried out in a community setting will often require approval from a local research ethics committee. This article discusses the processes, and problems, involved in seeking ethical approval, and sets out a framework for incorporating ethics committee approval into the design of a project.     

欧美生物仿制药注册制度及对我国的启示

目的完善我国生物仿制药注册制度。方法对欧洲生物仿制药审批指南体系和美国有望出台的BPCIA法案进行对比研究,并借鉴欧关经验指导我国实践。结果作为大分子药品,生物制品在药理特性、制备工艺等方面具有众多特性,这使生物仿制药注册必须进行更加精细的生物等效性验证。结论生物等效性验证不能直接被套用于生物仿制药注册,有必要对其进行更加严格的临床前和临床研究。     

药品注册审批工作中专利相关问题探讨

目的:探讨如何正确处理药品注册审批工作中的专利相关问题。方法:分析我国药品注册审批工作中专利相关规定及其存在的问题,并参照美国、欧盟的相关规定进行比较与分析。结果与结论:药品注册审批与专利权保护是相对独立的法律关系,分别适用药品管理法和专利法;药品注册审批与专利侵权之间没有必然联系;专利纠纷应当按照专利法的相关规定解决,药品注册审批工作不应当涉及药品专利纠纷的解决。     

美国医疗器械上市前审批制度介绍及其对我国的启示

目的：通过介绍美国高风险医疗器械产品的上市前审批(PMA)制度，希望对我国医疗器械审评审批制度的完善提供参考。方法：从申报方式、审评流程、沟通交流渠道等方面对美国高风险医疗器械产品的PMA制度进行介绍，并就事前沟通机制、模块化PMA申报路径和缴费流程前置等提出优化建议。结果与结论：美国PMA制度是医疗器械上市申报方式中最为严格的制度。其中，模块化PMA申报路径、多种交流渠道和缴费前置的申报流程均对我国医疗器械审评审批制度有较大参考价值。建议我国监管机构能够借鉴美国医疗器械PMA制度的有益做法，对我国监管体系进行不断优化和完善。