山东淄博在全国率先颁布器械管理地方性规章

近日，国家食品药品监督管理局将逐步建立完善引导药品生产企业加强创新药物研究的注册制度，对于仿制药品的注册申请将建立注册提示机制，即当某一品种的仿制注册申请达到一定数量时，发布提示信息，提醒生产企业和药品研发单位谨慎申请，进一步遏制企业对仿制药品无序申报的现象。     

国家食品药品监管局将建立仿制药注册信息提示机制

按照全国科技大会关于建立科技创新体制的要求，在药品注册中，国家食品药品监管局将逐步建立完善引导药品生产企业加强创新药物研究的注册制度，对于仿制药品的注册申请将建立注册提示机制，即当某一品种的仿制注册申请达到一定数量时，发布提示信息，提醒生产企业和药品研发单位谨慎申请，进一步遏制企业对仿制药品无序申报的现象。     

仿制药品的生物豁免

目前在我国上市销售的药品中，大多数为仿制药品，国外除了大公司原创药物较多外，仿制药品也占了相当的比例。仿制药品在促进市场竞争，降低药品价格，造福人民健康方面做出了重大贡献。根据我国现行的《药品注册管理办法》，仿制药品的申报需要向药事管理部门提供生物等效性研究资料。生物等效性是指两种制剂在相同试验条件下，服用相同剂量，其活性成分在吸收程度和速度上无显著性差异。目前国际通用方法一般采用生物利用度比较研究，即对不同时间点生物样本（如血浆、血清、尿液）中的药物含量进行测定，获得相应的AUC（曲线下面积）、Cmax（达峰浓度）、Tmax（达峰时间）等指标，根据临床经验预先制订的等效标准和限度评价拟上市药品和被仿制药品是否为等效制剂。     

中国鼓励仿制药品目录（第二批）品种特征及生物等效性研究要求

为及时满足国内临床用药需求，国家卫生健康委员会分别于2019年10月、2021年2月发布2批《鼓励仿制药品目录清单》。检索并整理了《鼓励仿制药品目录（第二批）》纳入品种的适应证、批准文号数量、临床试验登记等信息，结合美国食品药品监督管理局（FDA）发布的生物等效性研究个药指南，对目录中涉及的相关品种生物等效性研究要求进行梳理，结合品种特征与生物等效性研究要求进行了初步分析，以期为国内研究机构及企业开展相关研究提供科学依据与参考。     

算一笔投资非专利药的效益账

仿制厂家可以借助被仿制专利药已经开拓的市场,以药品通用化学名销售,基本不需要进行营销失言,可以节约大量的营销费用,同时由于仿制专利药品须要独特的技术,并且还要面临诉讼失败的风险,因此同类仿药竞争较小,可以获得较高的利润（药为销售收入的70%左右）。     

经口吸入制剂仿制药生物等效性评价过程中质量管理关键点探讨

经口吸入制剂通过搭载特殊的给药装置将药物递送至呼吸道和（或）肺部以发挥局部或全身作用,被用于治疗慢性呼吸系统疾病。目前,我国经口吸入制剂的使用仍以进口为主,患者用药成本较高,开展仿制药一致性评价将有助于降低患者经济负担。由于经口吸入制剂自身设计的特殊性和给药过程中的复杂性,在进行仿制药生物等效性评价过程中的准备阶段、进行阶段、结束阶段等关键环节把控好坏会直接影响临床试验质量,从而影响仿制药一致性评价结果。徐州医科大学附属医院是大型省属三级甲等综合医院,在经口吸入制剂仿制药生物等效性评价过程中积累了丰富经验。医院结合多年来开展经口吸入制剂仿制药生物等效性评价过程中的经验,对临床试验过程中质量管理的关键环节进行探讨,从而确保临床试验质量,有助于提升经口吸入制剂仿制药一致性评价能力,不仅降低患者用药成本,而且有助于提升国内经口吸入制剂仿制药行业整体水平。     

对仿制生物技术药物临床前评价的思考

对仿制生物技术药物的技术要求是目前国外业界一直存在争议的问题.文中对欧美药品注册管理机构对仿制生物技术药物的基本观点进行了回顾,并提出一些对于国内仿制生物技术药物(主要针对重组蛋白类药物)临床前药理毒理研究的个人观点.     

FDA对撒拌及经鼻胃管等特殊给药方式的固体口服仿制药生物等效性试验要求的分析

摘 要研究美国食品药品管理局（FDA）对撒拌及经鼻胃管等特殊给药方式的固体口服仿制药如何开展生物等效性试验的要求及相关指导原则,针对该类仿制药物关键质量属性、生物等效性试验的设计、体外鼻胃管对比试验等多个方面对FDA发布的《单项品种的生物等效性指导原则》中相关内容进行详细分析,为企业研发该类仿制药产品及开展相关品种的一致性评价工作及提供借鉴和帮助。     

世界新药之窗

"Bio-similar国际政策进展与解读"专栏[编者按]国外大规模的生物技术药物专利即将到期给全球制药企业带来了巨大的市场机遇。与化学仿制药不同,生物类似物(Bio-similar,国内一般称为生物仿制药)的安全性和有效性更依赖于充分的质量研究以及与原     

美国仿制药生物等效性评价的意义及方法

在美国,任何仿制药品上市,都必须经由美国食品药品监督管理局(FDA)批准.仿制药生产厂家须出示数据证明受试药品(仿制药品)与参比药品(原研药品)具有药学和生物等效性.生物等效性是指在相同的试验条件下,给予相同剂量的两种药学等效制剂,其活性成分吸收程度和速度无显著差异.     

FDA与EMA关于化学药申请Ⅰ期临床试验相关药学质量文件要求简介

FDA与EMA先后颁布了关于临床试验申请申报资料技术要求的指导原则,本文主要介绍其中关于新药Ⅰ期临床试验申请药学研究技术要求的相关内容,期望能对相关工作提供参考和借鉴,以加速我国创新药进入临床试验的时间.     

Regulatory considerations for generic or biosimilar low molecular weight heparins

The aim of the present paper is to address the legal aspects, technical requirements and possible conditions of use associated to low molecular weight heparin generics and biosimilars that are arriving to the market in United States and the European Union, respectively. To this end the concept of "similar biological medicinal product" that was coined in 2003 by the pharmaceutical legislation of the European Union is compared to the concept of generic in the United States and the concept of generic in the European Union. This different legal basis determines directly the technical requirements to obtain a marketing authorisation. Therefore, the chemical/biological, non-clinical and clinical requirements to demonstrate therapeutic equivalence are different in these two Regulatory Authorities, FDA and EMA. Consequently, the possible conditions of use are different. In the United States the products approved as generics by the FDA are considered interchangeable to the Reference Listed Drug. In contrast, the EMA legislation only deals with the approvability or prescribability of the medicines and it is a national / regional decision of the member States to consider these biosimilar products as interchangeable or not.     

The regulatory framework of biosimilars in the European Union

In the European Union (EU), the regulatory policy for biosimilars has enabled different biosimilar products to be marketed through an abridged application, which allows the applicant to submit a reduced dossier. Nevertheless, some manufacturers of biological products that share some characteristics with copies have opted for a full application; therefore, the number and extent of clinical studies required in these cases is increased. Here, we focus on a comparison of recombinant human erythropoietin medicinal products. We analyse and discuss clinical studies submitted to the European Medicines Agency that relate to available biosimilars and biological medicinal products that are authorised with a full dossier. We also discuss the issues of interchangeability and substitution, given that the EU allows each Member State to set their own substitution policies.     

EMA关于固定复方药物临床开发指导原则介绍

欧洲药品管理局（EMA）于2017年3月发布了关于固定复方药物临床开发的指导原则,该指导原则讨论了固定复方药物临床开发过程中的考虑要点和基本技术要求。我国目前尚无类似文件,通过对该指导原则的介绍,希望对我国固定复方药物的研发和审评工作提供参考。     

Special considerations concerning regulatory requirements and drug development for peptides and biotech products in the EU

The marketing authorization for a new medicinal product is based on the scientific assessment of its quality, safety and efficacy. The marketing authorization application (MAA) which covers all the relevant documentation can be filed in the EU via different application procedures. For peptides and biological products special issues have to be taken into consideration during drug development. Due to special production procedures and the complexity of the active substance itself, peptides and biotech products are subject to specific regulatory requirements. This leads to the necessity to discuss the development program of a new peptide or biotech product with the health authorities on a case by case basis. This article will focus on the special regulatory requirements for peptides and biotech products including the registration procedures as well as technical, preclinical and clinical issues.     

欧盟与我国GMP无菌药品附录差异分析与探讨

无菌药品作为高风险产品,生产过程和质量控制具有复杂性和特殊性,欧盟GMP附录1的发布对全球无菌药品的质量管理产生了巨大影响。为了解国际无菌药品生产质量管理的最新发展趋势与要求,把握我国无菌药品质量管理的现状,促进我国无菌药品质量提升,本文对欧盟与我国GMP附录1的主要差异点进行了分析和探讨,为我国GMP附录1的修订和无菌药品生产企业质量提升提供参考。     

Viral safety in homoeopathic medicinal products

To guarantee the safety of medicinal products as regards infectious agents, numerous national guidelines and recommendations have in recent years been included in the pharmacopoeia general monographs and have influenced the content of the substance monographs. Although the stipulations of the European Pharmacopoeia set out objectives, there is still a certain scope in how the requirements are implemented. This is reflected in the very different responses in Europe to the problems of safety from infection. Different traditions in the use of homoeopathic and anthroposophic therapy and varying levels of expertise among the regulatory authorities within the European Union have resulted in varying standard of assessment. The aim of this publication is to present a standard form of assessment for medicinal products in these therapeutic systems. Demonstrated hereunder is an approach that can be adopted to ensure that the high safety standard required is met for homoeopathic and anthroposophic medicinal products.     

Natural product guided compound library development

Natural products are biologically validated starting points for the design of combinatorial libraries, as they have a proven record of biological relevance. This special role of natural products in medicinal chemistry and chemical biology can be interpreted in the light of new insights about the domain architecture of proteins gained by structural biology and bioinformatics. In order to fulfil the specific requirements of the individual binding pocket within a domain family it is necessary to optimise the natural product structure by chemical variation. Solid-phase chemistry is becoming an efficient tool for this optimisation process, and recent advances in this field are highlighted in this review article.     

EMA对药用辅料右旋糖酐新的安全性评价

欧洲药品局（EMA）于2018年11月发布了"人用药品辅料右旋糖酐的包装说明书资料"，该文件引用大量文献全面评价了右旋糖酐的安全性，特别指出含有右旋糖酐辅料的注射和吸入制剂的疫苗与药品，应在说明书中描述有关其过敏反应信息的新要求。介绍该文件的主要内容，期望对我国这类药品说明书的撰写和监管有所帮助。