Issue: 49 Food and Drug Law Journal 397-400 (1994)
The system for establishing international biological standards has worked well for many years, with the World Health Organization acting as the primary focus for these activities. Pharmacopeias also serve an important role in providing working standards to the academic community and the pharmaceutical industry. There is a clear need for both types of standards, and it is essential that activities among the various organizations be coordinated and integrated to the greatest extent possible. Scientific and technological advances have caused a blurring of old distinctions between biologicals and drugs. These advances make it less necessary for many new products, such as some manufactured through biotechnology, to be standardized using the bioassay methods that were so important in the past. These advances also could help to make standards harmonization easier, but they raise questions about how biotechnology products should be regulated in the future.