World of Compliance Module

Biologics Regulation

Biologics have somewhat less regulation. OC's responsibilities for biologics include:

• Reviewing the chemistry, manufacturing and controls section of submitted applications and the supplements with the Prescription Drug User Fee Act timelines
• Conducting pre-license or pre-approval inspections required for licensure of the PDUFA products
• Conducting and participating in formal meetings with sponsors or applicants regarding the development and review of the products in human drug applications

Biologics are covered under the Public Health Services Act - Code of Federal Regulations (CFR)601.2. Categories of products that are submitted as biologics license applications (BLA) are therapeutic DNA plasmid products, therapeutic synthetic peptide products of 40 or fewer amino acids, monoclonal antibody products for in vivo use and therapeutic recombinant DNA-derived products.

Although both drugs and biologics are regulated under the Food, Drug and Cosmetic Act (FD&CA), there is a slightly different regulatory framework for biologics versus new drug products. Some small molecule products fit into both categories but are handled separately.