Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies. The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update. This cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also thoroughly discussed. The book is organized into six highly practical segments: Part I: CTD, eCTD, Module 1, and Environmental Risk Assessment Part II: CTD Summaries Part III: Quality Topics Part IV: Nonclinical Topics Part V: Clinical Topics Part VI: Other Topics (including drug-device combination products) This text is a must-have for those in the pharmaceutical industry determining regulatory requirements for the major world markets in Europe, the US, Canada, and Japan.

All medicinal products have to be licensed before marketing in any of the EEC, Nordic and EFTA countries. This book provides a systematic account of the major technical, administrative and legal requirements for registering a product in any of the national markets within the EEC, using the existing procedures, with guidance as to how these procedures are likely to change with the creation of a single European market in pharmaceuticals after 1992. The book should be of value to the pharmaceutical industry and their suppliers (the bulk excipient and active substance manufacturers); to government regulatory agencies; and to members of many technical, professional, scientific, medical and regulatory societies and organizations concerned directly and indirectly with medicinal products - particularly to members of the pharmaceutical and medical professions. There is an enormous interest in this subject in the EEC, the USA and Japan due to the likelihood of the creation in 1992 of a single market with some 350,000 patients.