Generic drugs provide significant public health benefits by providing high-quality, more affordable alternatives to brand name drugs. Approximately 90 percent of prescriptions dispensed in the United States are generic drugs that often are the product of an intricate global supply chain. The Office of Generic Drugs (OGD) is involved in
efforts to advance the international harmonization of scientific, technical and regulatory standards for generic drug development. The outcome of these global efforts is reduced time and cost of product development, consequently improving patient access to more affordable medicines. FDA’s efforts at international harmonization of standards for generic drugs will be reviewed. The financial impact of this harmonization on development costs and consequent easier access for patients to generic drugs will be discussed. The harmonization efforts would help regulatory agencies in the timely approval of generic drugs thereby accelerating access to affordable, safe, effective, and high-quality generic medicines for the American public.

Learning Objectives:
- Financial impact of harmonized international standards on global access to less expensive medications
- FDA’s operational modalities for generic drug approvals
- FDA’s efforts at international harmonization of scientific, technical and regulatory standards

Moderator:
- Mathew Cherian, ExCo Member, Industrial Pharmacy Section, FIP -

Panellists:
- Sarah Ibrahim, Associate Director, FDA, Center for Drug Evaluation and Research (CDER) - USA