International Pharmaceutical Product Registration

by Anthony C. Cartwright (Editor), Brian R. Matthews (Editor)

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 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.

854 pages, Hardcover

First published April 16, 2007

About the author

Anthony C. (Tony) Cartwright qualified as a pharmacist. He worked in the pharmaceutical industry, then for the UK Medicines Agency, for a contract company and then in his own company Global Regulatory Solutions.

His first books were all in the field of drug regulation. In his retirement he has written two books on the history of medicine, the first on the history of the British Pharmacopoeia, the next a history of drugs and dosage forms (ointments, creams, mixtures, tablets, capsules, inhalations, injections etc.)

His latest book to be published by Pen and Sword in November 2024 is a history of the antivaccination movements - "The Antivaxxers - A history of antivaccination and vaccination hesitancy" .