Minor Species, Who Cares?

摘要

The main reason why companies do not invest in the development of vaccines for minor species or minor indications is because of the lack of a proper return on the investment required. During the past ten years regulatory requirements on all aspects ofthe development (Analytical; Safety and Efficacy) have increased. In addition GLP, GMP and GCP regulations have come into force and are becoming stricter every year. Also, the perception of risk and what risk can be accepted has changed significantly towards a situation where the no-risk principle has become predominant in many EU countries. This has led to development times of between six to nine years for vaccines for veterinary use and development costs that have more than doubled during the last 10years (Fig. 1).