Guide to Drug Regulatory Affairs Europe By Brigtte Friese, Barbara Jentges, Usfeya Muazzam
Author: Friese, B.; Jentges, B.; Muazzam; U. with special contributions by T. A. Keller, C. Oldenhof, K. Olejniczak, H. Potthast, J. A. Schwarz, B. Sickmueller
Edition / publication year: 1st edition, 2007
Length: 1103 pages
Size, binding: 17 x 24 cm, hardcover
What is the ’Guide’ about?
This is the first comprehensive overview of the legal and regulatory
framework for marketing authorisation applications in Europe, including
Switzerland. It gives extensive and valuable advice on how to compile
a marketing authorisation according to the CTD format (Modules 1 – 5
Why has the ’Guide’ been developed?
The ’Guide’ has been developed to penetrate the ’regulatory jungle’ and make related work much easier and more efficient. With both a printed and a regularly updated online edition, the ‘Guide’ is a multi-media platform designed to support the different needs of its many users.
The ’Guide’ is subdivided into four major parts
- Part A: This provides detailed information about different procedures for drug approval, and relevant legislation and requirements that have to be considered when submitting an application for marketing authorisation. Judicial decisions from pertinent European courts are also highlighted.
- Part B: This gives detailed practical advice on how to prepare an application for marketing authorisation and also the accompanying documents which demonstrate quality, safety and efficacy. In addition, aspects of maintaining the marketing authorisation are discussed, covering applications for variations to a marketing authorisation, extension applications and renewal applications. Regulatory compliance issues are considered, and the requirements for IMPDs (Investigational Medicinal Product Dossiers) are included. Marketing authorisation procedures and the regional part of a Swiss marketing authorisation application are also considered.
- Part C: This describes the main provisions relevant to biopharmaceuticals, plant-based traditional medicinal products, blood, blood products and orphan drugs.
Part D: This includes much additional helpful information: an index of abbreviations, an index of terms and definitions, literature, links etc.