ABSTRACT
There are those in the biotech industry who would argue that biological medicinal products are too highly regulated and that the standards imposed for registration are too restrictive. It is certainly true that the number of regulations, guidelines, and other requirements relating to the registration of biological and biotechnological medicinal products has widened considerably in scope during the past two decades. However, this is due to the regulators seeking to keep pace with the rapid emergence of new technologies and product classes.
