International Conference on Harmonisation; guidance on electronic common technical document specification; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M2 eCTD: Electronic Common Technical Document Specification." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance defines the means for industry-to-agency transfer of regulatory information that will facilitate the creation, review, life cycle management, and archiving of the electronic submission. The guidance is intended to assist industry in transferring electronically their marketing applications for human drug and biological products to a regulatory authority.     

苏联法影响中国法制发展进程之回顾

在 2 0世纪中国历史上 ,苏联的革命法制理论和若干重要制度曾深刻地影响了中国的法制发展进程。孙中山曾主张“以俄为师”并进行过法制改革 ;中国共产党所领导下的人民民主政权的法制建设也是以苏联为标尺 ;新中国成立初期在创立社会主义法制的过程中 ,更是将苏联法全方位地移植到了中国。苏联法制为中国革命政党所接受与其自身的性质和中国革命的需要紧密相关。     

中国传统法研究中的几个问题

一个多世纪以来 ,传统法在中国常常被视为法治的绊脚石而受到责难。这种旷日持久的责难形成了种种偏见。比如在中西法的比较中习惯以西方法的理论、模式为标准来割裂传统法的有机组成 ;在论述传统法内容时局限于刑 ,而基本排斥了最具特色的“礼” ;过分强调法发展的一般规律 ,而忽视了不同文化背景下法所具有的特殊性。因此 ,在批判传统法的同时 ,我们需要反省对传统法的态度、反省研究中所持的标准、反省研究的方法 ,以求更准确、更合理地解读中国传统法     

About the Authors

Biography

About the Authors     

Introduction to special issue on ‘professional insecurities’

Introduction

Introduction to special issue on professional insecurities     

Commentaries on Brunner and Willard’s ‘professional insecurities’

Commentary

Commentaries on Brunner and Willards professional insecurities     

浅析延边中心城市优先突破战略

中心城市突破是实施延边州经济跨越式发展战略和实现延边“兴边富民行动”的客观要求。延边中心城市现代化战略目标的顺利完成必须从延边实际出发,制定并组织实施与延边经济社会发展全局有关的一些重大的发展战略。     

陕西国有资产管理体制和运行机制研究

陕西国有资产管理体制构想:统一归属,分类监管;党政一体,“三管”结合;政企分开,三层营运;属地纳税,收益分流。资本运营应规范和有效控制授权监督机制、“三管”结合机制、业积考核与评价机制。     

International Conference on Harmonisation; guidance on Q1A stability testing of new drug substances and products; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled "Q1A(R) Stability Testing of New Drug Substances and Products." The revised guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance sets forth recommendations on the information to be submitted in the stability data package for a new drug substance or drug product for a registration application within the three regions of the European Union (EU), Japan, and the United States. The purpose of there vision is to add information to certain sections and to provide clarification to other sections of the guidance.     

International Conference on Harmonisation; guidance on S7A safety pharmacology studies for human pharmaceuticals; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "S7A Safety Pharmacology Studies for Human Pharmaceuticals." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides a definition, general principles, and recommendations for the nonclinical safety pharmacology studies. The guidance is intended to help protect clinical trial participants and patients receiving marketed products from potential adverse effects of pharmaceuticals, while avoiding unnecessary use of animals and other resources.