Abstract

Although regulatory standards and procedures in Europe have improved following the establishment of the European Medicines Agency (EMEA), the number of major issues with marketing authorization applications for biotechnological products remains high. For example, the pivotal clinical trials of some late-stage failures have been found not to meet the regulatory guidelines of the European Union, and regulators are increasingly concerned that attempts to accelerate the process of biotechnological product development leads to the neglect of important issues. Based on the scientific decisions of the EMEA's major scientific committees, in this article we identify and discuss frequent concerns, and suggest approaches that might enable developers of biotechnological products to avoid these common pitfalls.

Author affiliations

1. Christian K. Schneider is at the Paul Ehrlich Institute, Federal Agency for Sera and Vaccines, Paul-Ehrlich-Strae 51-59, D-63225 Langen, Germany. He is also a member of the CHMP and member of the SAWP.
2. Gabriele Schäffner-Dallmann was previously in charge of antibody-containing products at the Paul Ehrlich Institute and was a member of the SAWP. She is currently at NDA Advisory Board, NDA Regulatory Science Ltd, Barnett Wood Lane, Leatherhead, Surrey KT22 7DE, UK.

Correspondence to: Christian K. Schneider¹ Email: schci@pei.de

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