The Changing Landscape of Regulatory Control of Biological Medicines

This paper focuses on the rapid growth in biological medicines in recent years brought about by advances in molecular biology and biotechnological manufacturing techniques. It looks at the implications for regulatory bodies and research institutions concerned with quality control of biologicals; and discusses ways in which the industry/regulatory/research partnership is evolving in response to the new situation. It argues that, although change is being managed relatively successfully in some areas of regulatory control (devolution to industry, use of new technologies, international harmonization), special measures may be needed in some other areas. These include: needs of the developing world for biologicals quality control; sustaining long-term research on safety issues and test methodology; major social and ethical issues raised by new treatment and diagnostic opportunities.