Vinod P. Shah, Ph. D., FIP/Chair SIG on Regulatory Sciences
Pharmaceutical Consultant, North Potomac, MD

The mission of a regulatory authority is to assure that safe and effective drugs are marketed in the country and are available to the people. FDA ensures that the generic drug products are safe and effective, are pharmaceutically equivalent and bioequivalent to the brand-name counterparts. The quality of the generic product is ensured thru product identity, strength, purity, assay, potency, content uniformity, dissolution (for solid oral dosage forms) and being manufactured under FDA’s good manufacturing practice.

The FDA has taken a lead in several initiatives towards global product safety and quality. Globalization has fundamentally altered the economic and security landscape of the medicines. The major concerns are related to the quality of the medicines and counterfeit. FDA is pursuing strategies to address these challenges, in particular building a close partnership with its foreign counterparts dedicated to building and strengthening product safety net around the world.

Presented at 2nd Zagreb International Conference on Pharmaceutical Sciences, Zagreb, Croatia, October 25-26, 2013