EMA Defines ‘Starting Material’ for Biological Manufacturers

The European Medicines Agency (EMA) has adopted new guidelines on the use of specific starting materials in nonrecombinant biologics. The new guidelines, which take effect Dec. 1, focus on two nonrecombinant biologics, in particular, heparins and urine-derived products such as gonadotrophins and urokinase. Due to generalities, the EMA says manufacturers have been using different definitions of the term “starting materials,” resulting in the need for defining a single term.
Drug Industry Daily