ICH M4E在中国实施的技术考虑

ICH M4是有关药品注册申请通用技术文件(common technical document, CTD)的指导原则,是为统一ICH各成员国/地区药品注册申报资料格式而制定。ICH M4E是其中关于药物临床资料申报的格式和内容。本文通过梳理中国药品注册申报临床资料要求的历史、探讨中国实施ICH M4E的特殊考虑、分析中国实施ICH M4E过程中面临的问题以及促进措施,旨在帮助申请人按照ICH M4E的要求进一步提高药物临床资料撰写的质量,进而有利加快审评进度并推进我国药物研发和监管的全球化。     

药物注册通用技术文件综述

目的 介绍了人用药品注册规范化文件的编写格式.方法 全面介绍通用技术文件(CTD)的具体章节内容和写作格式.结果与结论 对有意打开国际市场的我国制药企业编写规范的注册文件起到指导作用,推动我国制药企业的国际化进程.     

ICH质量指南和统一技术文件

ICH的历史 ICH,即国际人用药品注册技术要求协调会议,是一个独一无二的项目.它将欧洲、日本和美国制药工业和监管机构的专家,以及一些观察员和感兴趣的组织汇集到一起,讨论产品注册的科学和技术问题.ICH的目的是提出方法以实现关于产品注册的技术指南和要求的进一步协调,从而减少新药研发阶段的重复检测.     

我国实施ICH Q系列技术指导原则的策略研究

通过对ICH Q系列指导原则与我国对应技术指导原则的对比研究,分析我国药品注册药学技术要求与ICH药学技术要求的主要差异。通过对公众、专家、企业进行问卷调查,摸清ICH Q系列指导原则在我国的认知和实施基础。在对比研究和问卷调查的基础上,结合ICH的要求,提出了ICH Q系列指导原则在我国实施的建议。     

我国实施ICH E系列技术指导原则的策略研究

通过对ICH E系列指导原则与我国对应技术指导原则的对比研究,分析我国与ICH在药品注册临床技术要求方面的主要差异。通过对公众、专家、企业进行问卷调查,摸清ICH E系列指导原则在我国的认知和实施基础。在对比研究和问卷调查的基础上,结合ICH的要求,提出ICH E系列指导原则在我国实施的建议。     

浅析中国药物临床试验管理规范与国际通用准则的异同点

依据中国2003年颁布实施的药物临床试验质量管理规范(GCP)与人用药品注册技术要求国际协调会议(ICH)GCP的相关内容,本文将中国GCP各章节内容与ICH GCP进行比较,分析两者间存在的异同点,以期为推动中国GCP制度的改革与发展提供参考.     

我国实施ICH S系列技术指导原则的策略研究

通过对ICH S系列指导原则与我国相应技术指导原则的对比研究,分析我国与ICH在药品注册非临床技术要求方面的主要差异。通过对公众、专家、企业进行问卷调查,摸清ICH S系列指导原则在我国的认知和实施基础。在对比研究和问卷调查的基础上,结合ICH的要求,提出了ICH S系列指导原则在我国实施的建议。     

《药物生殖毒性研究技术指导原则》与ICH S5(R2)指导原则的对比研究及实施建议

介绍国家食品药品监督管理总局药品审评中心(CDE)和人用药品注册技术要求国际协调会(ICH)对药物生殖毒性研究指导原则的内容,比较不同机构对生殖毒性非临床评价要求,包括ICH S5(R2)指导原则和国内相关领域指导原则的对应关系、我国指导原则与ICH S5(R2)的差异等内容,对ICH S5(R2)在我国实施的可行性存在的技术困难和法规方面的障碍进行了讨论,并根据CDE和ICH指导原则的差异对比情况对我国实施ICH S5(R2)给出了建议,以期为国内新药的生殖毒性评价提供借鉴。     

化学创新药审评中基于ICH Q11的考虑

国际人用药品注册技术协调会(ICH)Q11是原料药开发和生产的技术指导原则，系统阐述了原料药工艺开发的基本方法和起始原料的选择原则；ICH Q11问答文件进一步阐述了选择起始原料的具体要求。本文参考ICH Q11及问答文件的要求，围绕创新药药学研究的阶段性规律，讨论化学创新药技术审评中基于ICH Q11的考虑。     

ICH指导原则与各国现行药典药品的残留溶剂分析方法概述

人用药品注册技术要求国际协调会议(International Conference of Harmonizition ICH)对药品残留溶剂的指导原则[1],对残留溶剂有明确的定义.各国药监部门也曾使用不同的药品残留溶剂指导原则.为此国际组织展开了协调工作,制定了相关的指导原则,而多数国家的药典也按照此原则制定对残留溶剂的测定方法.下面就围绕这几方面对残留溶剂分析方法进行概述.     

Summary of the 34th Annual Meeting of the Drug Information Association

A variety of issues relating to clinical aspects of drug development were discussed at the 34^th annual meeting of the Drug Information Association. Among the topics covered at this conference were the following: 1, development of CNS compounds; 2, the Common Technical Document (CTD); and 3, labelling of drugs for use in pregnancy. Issues surrounding the development of CNS compounds were discussed by regulatory authorities from the USA and Europe. In almost all aspects covered, the regulatory requirements for approval in Europe appear to be consistent with those in the USA. Efforts aimed at developing a CTD are ongoing under the auspices of the ICH. The goal of this effort is to develop a common technical information package that can be submitted to regulatory authorities in the USA, the EU and Japan. It is recognised, however, that a number of sections of regulatory submissions will remain outside of the CTD. New initiatives in the labelling of drugs for use in pregnancy in the USA were reviewed. These efforts are being led by the Pregnancy Labeling Task Force of the USA FDA. The overall goal of this effort is to more clearly define by labelling, the relative risks of pharmaceutical agents that must be administered to pregnant women.     

Impact of the last 15 years: from PMDEC to PMDA --looking back at the first stage of the PMDEC

The Ministry of Health and Welfare (MHW) (renamed the Ministry of Health, Labour and Welfare [MHLW] in Jan. 2001) amended the Pharmaceutical Affairs Law, resulting in a fundamental reform of the review system for New Drug Applications, based on the 1996 report of the ad-hoc Committee for Drug Safety Ensuring Measures. One of the most important changes in the review system was the establishment of the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC) on July 1, 1997 followed by the Pharmaceuticals and Medical Devices Agency (PMDA) in 2004. In five years, the drug approval system in Japan underwent a series of significant reforms, such as adopting new GCP based on the ICH/E6 (R1), changes relating to ethnic factors in the acceptability of foreign clinical data (ICH/E5 (R1)), and the establishment of a Common Technical Document (CTD) (ICH/M4). The addition of the PMDEC has greatly improved the speed of review for new drugs, especially oncology drugs and orphan drugs. We discuss the philosophy of PMDA in relation to the concept of regulatory science.     

Implementation strategy for eCTD electronic submission in China based on experiences from ICH countries

With the development of information technology and pharmaceutical science, eCTD (electronic common technical document) has gradually become the main format for pharmaceutical registration dossiers all over the world, especially the ICH (the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) countries. In 2015, CFDA (China Food and Drug Administration) emphasized the significance of establishing a uniform specification for registration applications, extensively applying CTD format in China and enforcing eCTD electronic submissions step by step. In this study, we summarized the international experiences on implementation of eCTD from ICH countries and analyzed China’s current regulatory status. A survey was carried out to investigate the feasibility of implementing eCTD electronic submission in China, the possible problems to be faced with and the related solutions. Finally, recommendation on eCTD implementation strategy in China was proposed.     

Summary of the 34th annual meeting of the Drug Information Association

A variety of issues relating to clinical aspects of drug development were discussed at the 34(th) annual meeting of the Drug Information Association. Among the topics covered at this conference were the following: 1, development of CNS compounds; 2, the Common Technical Document (CTD); and 3, labelling of drugs for use in pregnancy. Issues surrounding the development of CNS compounds were discussed by regulatory authorities from the USA and Europe. In almost all aspects covered, the regulatory requirements for approval in Europe appear to be consistent with those in the USA. Efforts aimed at developing a CTD are ongoing under the auspices of the ICH. The goal of this effort is to develop a common technical information package that can be submitted to regulatory authorities in the USA, the EU and Japan. It is recognised, however, that a number of sections of regulatory submissions will remain outside of the CTD. New initiatives in the labelling of drugs for use in pregnancy in the USA were reviewed. These efforts are being led by the Pregnancy Labeling Task Force of the USA FDA. The overall goal of this effort is to more clearly define by labelling, the relative risks of pharmaceutical agents that must be administered to pregnant women.     

ICH国际医学用语词典(MedDRA):药事管理的标准医学术语集

ICH国际医学用语词典（MedDRA）在ICH主办下创建,是供政府药事管理部门与生物制药工业管理新药上市前后的临床研究各阶段的标准术语集。该术语集支持各种临床数据的编码、检索与分析,如不良事件、医学与社会史、适应症与临床检查。本文叙述了MedDRA的创建原因与历程等背景信息,MedDRA术语的分级结构,MedDRA的规则与习惯,MedDRA在数据编码与分析中的应用,以及ICH参加国/地区政府对MedDRA使用的行政要求。最后探讨了MedDRA在中国推广使用的前景。     

Clinical evaluation of QT/QTc prolongation and proarrhythmic potential for nonantiarrhythmic drugs: the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use E14 guideline

Proarrhythmias due to drug-induced QT prolongation are the second most common cause for drug withdrawal and have caused increasing concern. Two new International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines were recently endorsed in which nonclinical (S7B) and clinical (E14) methodologies are discussed and guidance is given to the industry. This commentary describes the key components of the E14 document, the impact of nonclinical testing on the clinical program, the thorough QT study, and the impact of its result on late-stage development. The studies described in S7B and E14 will contribute to a better understanding of the link between nonclinical assays and QT prolongation in humans. Differences in interpretation among individual regulators in the major regions with respect to measures proposed in the E14 guideline might impact regional regulatory decisions. These differences include the value of nonclinical assays for the subsequent clinical testing and how predictive a negative thorough QT study result is for proarrhythmic risk in patients.     

Pharmacovigilance-related topics at the level of the International Conference on Harmonisation (ICH)

Marketing authorisations for medicines need to be based on the universal criteria quality, safety and efficacy, whilst taking into account local public health needs. With view to using resources efficiently and avoiding delay in access to medicines, scientific standards for investigating quality, safety and efficacy should be universal too. A major step to achieve this was taken in 1990 when the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was established between authorities and industry in the European Union (EU), Japan and the United States. Since then more than 50 ICH Guidelines have been published, out of which six are specific to pharmacovigilance. They refer to management and expedited reporting of individual adverse drug reaction (ADR) cases, including electronic formats, periodic reporting of worldwide data and planning of pharmacovigilance. Their development has to be seen in the context of initiatives taken in the three ICH Regions to strengthen pharmacovigilance. Most recently this involves making use of risk management concepts, reflecting new thinking of proactivity in pharmacovigilance. Moreover, consideration is given to regional and international cooperation beyond the ICH Regions.     

Objectives and organization of the International Conference on Harmonization]

The objective of the International Conference on Harmonization established since 1989 is to allow marketing of new drugs as soon as possible for patient benefit. At the same time harmonization decreases development time by harmonizing the content and the format of the registration file in the three regions: European Union, United States and Japan. ICH is a unique process involving health authorities and industry representatives of the three regions. The Conference which took place in July 1997 was the end of the first step of the process. At the meeting it was decided to pursue this harmonization activity, particularly in initiating a project devoted to the file format (Common Technical Document). The current period will be essentially focused on implementation of the common Guidelines and on their update in relation to scientific progress, the major part of the file now being harmonized in its content.     

对医疗器械标准技术委员会管理的几点思考

定位医疗器械标准技术委员会（以下简称：标技委）的职责,探求对其科学管理,最大限度发挥其作用,有效为医疗器械监管工作服务,是医疗器械监管工作的重要组成部分。从医疗器械内在特点出发,结合工作实际,提出对标技委管理的方法和措施,为标技委的管理实践提供参考。