Influence of regulatory systems: The European CPMP perspective

Abstract

1. The CPMP has established a robust and transparent review system for marketing applications which allows discussion with the industry at specific points in the process. This interaction will give industry early notice of the common European position on, for example, the preclinical animal safety studies submitted to support the marketing application. Industry can also turn to the CPMP for advice during drug development on specific issues not covered by existing guidance. This procedure could be particularly valuable for biotechnologically-derived products which often are documented on a case-by-case basis.