Definition, categorization, and environmental risk assessment of biopharmaceuticals

Biopharmaceuticals are associated with the revolutionary treatment of various diseases, and according to European Medicines Agency, biopharmaceuticals derived from biological sources perceived not cause significant environmental risk. However, there is currently no broadly recognized definition or categorization despite fact that improved technology has made it possible modify them obtain more efficient medicines, thereby raising questions about their origins risks. The aim this paper, based on a literature review, derive clear evaluate Union's regulation risk assessment (ERA) procedures for them. Nine different definitions were identified, evident term “biopharmaceuticals” used ambiguously. We therefore recommend defined as complex molecules source, purpose diagnose, prevent, treat, cure diseases conditions human beings. Furthermore, we should be categorized structure: 1) amino acids, 2) nucleic 3) vaccines. Only 11 studies identified being relevant ERA, lack useful data hazard identification. More research needed examine ecotoxicity, fate, stability most biopharmaceuticals—and categorical regulatory exclusion seems unfavorable in regard.