ABSTRACT
The diversity and complexity o f these products present new regulatory challenges, because specific standards for the criteria o f safety, purity and potency for these products may not exist and current experience largely relies on animal models. The problem is further complicated by the variety o f regulatory submissions for prevention o f viral, bacterial and parasitic diseases. Therefore, the safety, purity and potency o f these products are evaluated using a case-by-case approach that is product-specific and indication-based. Consideration is also given to potential risks versus the benefits o f using the product in the target population. It is important to realize that regulatory policy evolves in response to advances in technologies. Thus, the purpose o f this chapter is to provide a framework for product characterization from which preclinical and clinical testing strategies will need to be developed according to current knowledge and state-of-the-art technology.
