Collaborative Study for the Establishment of a National Reference Preparation for Erythropoietin

National regulatory authority have the duty to ensure that available pharmaceutical products are of the required quality. This is particularly difficult for biotechnological products, the quality of which cannot be established entirely by test on the material in the final container. In general biotechnological products are distinguished from other drugs by being derived from genetically modified microorganism to humans, and frequently have a complex molecular structure. (omitted)