Typical pitfalls in applications for marketing authorization of biotechnological products in Europe.
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.
Schneider
Christian K
CK
Paul Ehrlich Institute, Federal Agency for Sera and Vaccines, Paul-Ehrlich-Strabetae 51-59, D-63225 Langen, Germany. schci@pei.de
Schäffner-Dallmann
Gabriele
G
D001709:Biotechnology / Q000191:economics / Q000331:legislation & jurisprudence / Q000592:standards; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005060:Europe; D033161:Government Regulation; D017408:Guidelines as Topic; D040541:Marketing / Q000331:legislation & jurisprudence*