药品注册申报资料的现状与问题（五） ——生物等效性试验

 药品注册申请资料的完整性和研究数据的可溯源性,是开展药品技术审评的必要前提条件。通过对中药和化学药品的改剂型、仿制药注册申请资料的审查分析,从管理信息、药学、药理毒理、生物等效性研究等方面,对药品注册申报资料的现状与常见问题加以阐述,希望引起注册申请人的关注。本篇重点阐述生物等效性试验资料要求。 ［关键词］　药品注册;申报资料;生物等效性     

药品注册申报资料的现状与问题（一） ——基本信息和管理证明性文件

 药品注册申请资料的完整性和研究数据的可溯源性,是开展药品技术审评的必要前提条件。通过对中药和化学药品的改剂型、仿制药注册申请资料的审查分析,从管理信息、药学、药理毒理、生物等效性研究等方面,对药品注册申报资料的现状与常见问题加以阐述,希望引起注册申请人的关注。本篇重点阐述管理信息资料要求。     

药品注册申报资料的现状与问题（四） ——药理毒理研究资料

 药品注册申请资料的完整性和研究数据的可溯源性,是开展药品技术审评的必要前提条件。通过对中药和化学药品的改剂型、仿制药注册申请资料的审查分析,从管理信息、药学、药理毒理、生物等效性研究等方面,对药品注册申报资料的现状与常见问题加以阐述,希望引起注册申请人的关注。本篇重点阐述药理毒理资料要求。     

药品注册申报资料的现状与问题（二） ——化学药品药学研究

 药品注册申请资料的完整性和研究数据的可溯源性,是开展药品技术审评的必要前提条件。通过对中药和化学药品的改剂型、仿制药注册申请资料的审查分析,从管理信息、药学、药理毒理、生物等效性研究等方面,对药品注册申报资料的现状与常见问题加以阐述,希望引起注册申请人的关注。本篇重点阐述化学药品药学研究资料要求。     

广东省药品注册申报存在的问题分析与建议

目的:为药品注册申报提供参考。方法:收集2015年国家食品药品监督管理总局对广东省申报药品不予批准的审批意见,分析临床试验和注册生产两个阶段中药品注册申报存在的问题,并根据相关的政策法规提出建议。结果与结论:化学药申报临床试验阶段被退审的原因主要集中在已有进口药品注册申请批准或该新药进入监测期;而药学研究质量缺陷,特别是杂质、有关物质研究不充分是申报临床试验和申报生产中的主要问题。针对临床试验申报,申请人应适应新的药品注册分类改革,加强原始创新药物研制,生物制品开发应建立全面有效的生物制品评价体系,形成优势技术和产品;针对注册生产申报,相关部门或药物生产企业应加强对药品剂型和规格设计的合理性评价,仿制药应注重与原研药品的一致性评价。除此之外,还可通过建立科学可行的杂质、有关物质研究方法,注重前瞻性生产工艺的放大研究等解决上述问题。     

化药及生化药注射剂再注册审查要求与注意事项

目的说明注射剂再注册的审查要求与注意事项。方法结合审查中申报资料存在的一些问题,就生药及生化药注射剂再注册基本原则、申报资料项目及重点问题进行了述要。结果与结论申请人认真学习药品再注册相关文件,能提高再注册申报资料质量,从而顺利高效地完成药品再注册工作。     

药品注册申报资料的现状与问题（三） ——中药、天然药物药学研究资料

 药品注册申请资料的完整性和研究数据的可溯源性,是开展药品技术审评的必要前提条件。通过对中药和化学药品的改剂型、仿制药注册申请资料的审查分析,从管理信息、药学、药理毒理、生物等效性研究等方面,对药品注册申报资料的现状与常见问题加以阐述,希望引起注册申请人的关注。     

ICH M4模块一中国行政管理文件制定及实施的考虑

为推动中国药品注册申报资料递交标准与国际接轨,提高药品注册和审评审批效率,本文深入探讨了中国ICH M4模块一文件制定及实施的关键考虑.通过梳理分析国外先进监管机构M4模块一文件特点,基于药品注册申报科学高效管理的考量,制定形成中国M4模块一文件的要求.与ICH M4中涉及药物质量、安全性和有效性相关技术资料的其他4个...     

FDA药-械组合产品桥接指导原则介绍

美国食品药品管理局(FDA)的"供企业用药-械和生物制品-器械组合产品的桥接指导原则(草案)"详细描述了药-械组合产品注册申请人,利用另外的开发方案产生的信息,作为拟开发产品的注册资料(即桥接),替代试验研究资料的方法,支持拟申报产品的批准;推荐渐进式5步骤法,确定桥接策略和信息需求并列举了3个示例予以解读。详细介绍该指导原则的内容,期望为中国药-械组合产品研发和监管开辟新思路,建议在合适的条件下可考虑利用"桥接"方法减少试验研究,加速研究进程,缩短研究周期,节省研究经费,促进药-械组合产品的开发。     

药学研究资料综述撰写的基本考虑(二)

药学研究是药物研发的重要组成部分,是药物进行安全性、有效性研究的基础。药学研究资料综述应体现申报品种整个药学研究工作的总结、分析和自我评价内容,它对于注册申请人以及技术审评人员全面、系统地了解申报品种的药学研究内容具有非常重要的意义。文中根据相关技术指导原则,对药学研究综述资料的撰写内容以及需关注的相关技术问题进行了阐述,供药品注册和药学研究工作者参考,以提高注册质量和效率。     

指导原则解读系列专题(十七) 药学研究资料综述撰写的基本考虑(一)

药学研究是药物研发的重要组成部分,是药物进行安全性、有效性研究的基础。药学研究资料综述应体现申报品种整个药学研究工作的总结、分析和自我评价内容,它对于注册申请人以及技术审评人员全面、系统地了解申报品种的药学研究内容具有非常重要的意义。文中根据相关技术指导原则,对药学研究综述资料的撰写内容以及需关注的相关技术问题进行了阐述,供药品注册和药学研究工作参考,以提高注册质量和效率。     

药品经营与管理专业人才培养模式和课程体系的构建

目的:构建高等职业教育药品经营与管理专业人才培养模式及课程体系。方法:针对当前药品经营与管理专业存在的问题,并结合高职高专的特点,设置药品经营与管理专业岗位群的人才培养方案和课程模块。结果与结论:我院药品经营与管理专业采用了"模拟职场教学""工学结合教学""顶岗实习"培养模式,以职业岗位发展设置课程模块,以工作过程为导向构建课程体系,以能力培养为核心构建实践教学课程,建立了学校、学生与企业相结合的考核评价体系。     

Role of modelling and simulation: a European regulatory perspective

Modelling and simulation (M&S) of clinical data, e.g. pharmacokinetic, pharmacodynamic and clinical endpoints, is a useful approach for more efficient interpretation of collected data and for extrapolation of knowledge to the entire target population. This type of documentation is included in the majority of marketing authorization applications for new medicinal products. This article summarizes the current status of regulatory review with respect to the role of M&S in Europe from the perspective of the Swedish Medical Products Agency. At present, regulatory bodies in Europe encourage the application of the M&S approach during drug development. However, there is a lack of consensus and transparent guidance documents. The main regulatory usage is in the evaluation of dose choices in sub-populations and as support for the dosing regimen in general. The regulatory review of conestat alfa illustrates how the dose recommendation was revised during the approval procedure based on M&S information. A survey of marketing authorization applications for new medicinal products approved in 2010 revealed that the use of the information gained from M&S documentation varies with respect to both regulatory review and the applicants' presentation of the data in the submitted dossier. Increased utilization and broadened application of M&S is anticipated in pharmaceutical development, where one area of focus is medicines for paediatric patients. Accordingly, the regulatory agencies will need to increase their capability to assess and utilize this type of information, and an interactive process among regulatory agencies is warranted to provide more unified regulatory assessment and guidance. Moreover, applicants are encouraged to expand on the usage of exposure-response models to map the systemic exposure range that yields safe and efficacious treatment and to improve the presentation of the gained knowledge in summary documents of the marketing authorization applications.     

我国医药冷链体系的现状及其发展建议

目的:为我国医药冷链体系的发展与规范提供参考。方法:通过文献研究,对我国医药冷链体系发展现状及存在的问题进行分析。结果:我国冷藏药品城市市场需求大,农村市场前景广阔;政府与媒体已开始关注医药冷链体系的发展。但冷链体系发展过程中仍存在诸如"药品冷冻过度"和"中药冷链"问题不受重视、"药品冷链末端配送"让人担忧、第三方医药物流不被信任、硬件设施与冷链管理理念落后、相关人员素质不高等问题。结论:建议引导各方关注"药品冷冻过度"和"中药冷链"等问题,成立统一配送中心,改善道路交通,不断完善医药冷链末端配送体系;通过完备相关法律政策,加大对于第三方医药物流的扶持;通过自筹资金、引进国外先进管理理念促进冷链体系发展;从企业和政府两个方面共同加强人员的专业培训等。     

门诊抗菌药物处方点评与分析

目的：了解门诊抗菌药物处方情况,促进医院合理用药。方法：抽取中山大学肿瘤防治中心2013年第1李度门诊抗菌药物处方1364张,以《处方管理办法》、《新编药物学》、《抗菌药物临床应用管理办法》、《中华人民共和国药典·临床用药须知》、《抗菌药物临床应用指导原则》为依据,以《医院处方点评管理规范（试行）》《广东省处方点评实施规范（试行）》为标准,从书写规范性及用药合理性角度,判断不合理处方并进行归类分析。结果：不合理处方1199张,其中书写不规范和用药不适宜处方分别为1168张（占97．41％）、31张（占2．59％）,前者主要表现为医师无指征延长用药疗程、处方临床诊断书写不全等,后者主要表现为用法与用量不适宜、适应证不适宜、遴选的药品不适宜等。结论：我院门诊抗菌药物处方书写不规范处方比例仍较高,抗菌药物的使用仍存在一定问题,需进一步加强药师审方制度,改善合理用药监督反馈管理环节,进一步提高门诊抗茵药物处方合理率。     

AMCP Format dossier requests: manufacturer response and formulary implications for one large health plan

BACKGROUND: The Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions, a template for health plans to use in developing formulary submission guidelines, has been widely adopted since its initial release in 2000. Many health plans request a dossier (a standardized set of clinical and economic evidence prepared by pharmaceutical manufacturers) to provide information for consideration during the formulary decision-making process. While dossier quality has reportedly improved over time, there is no recent research examining the response rate to dossier requests and the quality of dossiers received. OBJECTIVE: To perform an evaluation of pharmaceutical manufacturers. response to a request for a product dossier prepared using the AMCP Format, and to determine if dossier receipt was associated with a favorable formulary placement. METHODS: The pharmacy and therapeutics (P&T) committee of a mid-Atlantic health plan with approximately 3 million members reviewed 43 drug products from February 2004 through December 2005. A university-based clinical evaluation subcontractor requested dossiers in the AMCP Format by telephone and e-mail from the manufacturers. drug information center about 8 weeks before the committee meeting. A retrospective evaluation of the materials received from the manufacturers was performed. A logistic regression model was developed to determine if dossier receipt increased the likelihood of second-tier copayment formulary placement for new product reviews. RESULTS: Dossiers were requested for 43 products. We received dossiers for 25 products (58%), other drug information (e.g., journal reprints, product labeling) for 10 products (23%), a formulary kit for 4 products (9%), and no response for the remaining 4 products (9%). Of the 25 dossiers, 21 (84%) generally followed the AMCP Format. Unlocked interactive budget impact models were included in 5 dossiers (20%), and modeling reports (without an unlocked interactive model) were included in 12 dossiers (48%). Dossiers were more likely to be received when the time between U.S. Food and Drug Administration (FDA) approval and dossier request was >/- 4 months (65% vs. 27% when <4 months; P <0.05) and when requested from a large manufacturer (top 25 in sales) compared with smaller manufacturers (75% vs. 43%; P <0.05). Dossier receipt did not improve a product.s likelihood for preferred formulary placement; none of the new products for which dossiers were received were assigned to the second copayment tier compared with 33% of the new products with no supporting dossier. The logistic regression model failed to find any correlation between dossier receipt and preferred formulary placement. CONCLUSIONS: Manufacturers met the request for a dossier nearly three fifths of the time. The dossiers were of high quality and generally followed the AMCP Format; the models included in dossiers varied widely in their design and utility. The product manufacturer.s size and the time between FDA approval and dossier request influenced the likelihood of dossier receipt. Receipt of a dossier did not appear to influence the likelihood of a product attaining preferred formulary status.     

综合医院评审中发现的药事管理相关问题与改进探讨

目的:为提高二级综合性医院药事管理水平提供参考。方法:按《贵州省医院管理年评价指南(试行)实施细则》对本地区2家三级和6家二级综合性医院进行评审,分析药事管理存在的问题,探讨改进措施。结果与结论:二级综合性医院药事管理硬件建设基本达到要求,但管理水平相对偏低,在临床药学的开展、抗菌药物的合理使用及特殊药品的管理等方面与评价指南要求仍有相当差距。应加强内涵建设,规范管理,促进医院药事管理持续发展。