REGULATORY REQUIREMENTS ON 3D BIOPRINTING BIOLOGICS: A COMPARATIVE ANALYSIS OF USFDA AND EUROPEAN UNION PERSPECTIVES

Dr. Ashok Kumar P.*, Prajval Shreekant Hulagejji, Likhith Gowda C. H., Sharath B., Jnanesh R., Raghu K. P.

ABSTRACT

Biologics, A Rapidly Evolving Class of Medical Products Derived from Living Sources, Are Stringently Regulated by the Food and Drug Administration (FDA) In THE USA Under the Public Health Service Act and The Federal Food, Drug, and Cosmetic Act.[1] The Approval Process Necessitates Extensive Clinical Trials, A Biologics License Application (BLA) Review, and Adherence to Manufacturing, Labelling, And Post-Marketing Surveillance Guidelines to Ensure Safety and Efficacy.[2] 3D Bioprinting Represents an Innovative Technology Combining Biological Materials with Additive Manufacturing to Fabricate Organs and Tissues for Therapeutic Applications. This Review Examines Key Bioprinting Techniques, Including Extrusion-Based, Inkjet, And Laser-Assisted Methods, And Highlights the Crucial Role of Bioinks (Synthetic and Natural Polymers) In Tissue Development. While Offering Revolutionary Prospects for Healthcare and Tissue Engineering, 3D Bioprinting Faces Significant Technological, Manufacturing, Material Selection, And Regulatory Challenges. This Article Examines the Regulatory Approval Processes for Biologics in the United States, interprets 3D Bioprinting Innovations and Applications, and Discusses Current Regulatory Perspectives, As Well As the Ethical, Legal, and Social Aspects, Future Trends, and Associated Risks Within This Rapidly Advancing Field

Keywords: Food And Drug Administration (FDA), Biologics, 3D Bioprinting, Bioinks, Tissue Engineering, Biologic Therapies.