This publication, Global Biotechnology Product Registration, provides a comprehensive analysis of the Center for Biologics Evaluation and Research (Cber) and its review process for biological and biotechnology products. Global Biotechnology Product Registration is divided into three discrete sections covering the European Union, the United States, and Japan. From preclinical product development to postmarketing approval, each section provides comprehensive and up-to-date analyses of the biotechnology product approval process in a different major market.
Authors: Mark M. Struck, Ph.D., Mark Mathieu, and Hiromi Okabe, Ph.D.
Part 1 - The European Union Chapter 1 - Introduction Chapter 2 - Preclinical Testing Chapter 3 - Clinical Research and Development Chapter 4 - Manufacturing and Aspects of Quality Chapter 5 - European Regulatory Bodies Chapter 6 - The Marketing Authorization Application (MAA) Chapter 7 - Marketing Authorization Application Review Procedures Chapter 8 - Postlicensure Activities Appendices References
Part 2 - Japan Chapter 1 - Historical Perspective Chapter 2 - Overview of Japan's Regulations for Biopharmaceuticals Chapter 3 - Submissions and Confirmation of Manufacturing Plans Chapter 4 - Technical Requirements Chapter 5 - Nonclinical Testing Requirements for Japan Chapter 6 - Requirements for Clinical Trial Initiation: The Clinical Trial Notification Chapter 7 - Clinical Trials in Japan Chapter 8 - The NDA Synopsis Chapter 9 - NDA Review and Approval Chapter 10 - Post-Approval Requirements Closing Remarks
Part 3 - The United States Chapter 1 - Introduction Chapter 2 - Preclinical Safety Assessment of Biological Products Chapter 3 - The IND for Biological Products Chapter 4 - CBER and the Biotech IND Review Process Chapter 5 - Clinical Studies in the Development of Biologic Therapeutic Products Chapter 6 - The Biological License Application (BLA) Chapter 7 - CBER's Licensing Application Review Process Chapter 8 - Postlicensure Requirements
Appendix 1 - Selected CBER and ICH Guidelines Relevant to Biotechnology Products