The regulation of biological products

Abstract

The purpose of regulations for biological products is the same as that for any other medicinal or related products: the protection of recipients of the products. The entry into the age of molecular biology with its attendant development and manufacturing technology has placed new demands on regulatory agencies and related industry personnel. While the general goals of regulations remain the same, the scientific bases by which biological products must be reviewed and registered vary from those traditionally used for drugs or even older vaccines produced by conventional methods of growth, harvesting and purification. New regulations must be developed which take into account the new science involved in molecular biology and recombinant technology; new definitions must be provided and widely understood. The regulation of biologic products on an international basis is complicated by issues such as national interests superceding individual patient needs, bureaucracies being driven primarily by regulation and secondarily by science, industry expecting priority treatment for innovative products while having to absorb costs related to lost regulatory review time, and agencies or industry relying upon outdated regulations and/or archaic tests. While many problems remain within the regulatory process, some due to regulations, some due to the nature of the agencies, some due to the needs and desires of industry, it is clear that for any segment of development and application of a biological product, answers to the following questions which are clear and complete will preclude most problems encountered in the review of applications: for a given seed or process, what action was taken at each step, what alternatives existed, why was the seed or process selected, and what validation was there for each step. Utilisation of this approach will help to preclude most serious problems during the review process of contemporary biological products.