How The FDASIA Can Affect Your Supply Chain

By Dr. Guo, VP of pharmaceutical and quality services, AMRI

The supply chain for active ingredients and drug products in the pharmaceutical industry is becoming more complex as globalization in the world economy continues. Globalization provides benefits for costeffective solutions, enhanced security, and stability for the supply chain. On the other hand, companies therefore need a more sophisticated approach to manage their global supply chain. After all, suppliers in individual countries operate under their own regulatory, environmental, and cultural norms and requirements.

Key info About The FDASIA
As part of the U.S. effort to modernize regulation for the 21st century, the U.S. FDA Safety and Innovation Act (FDASIA) was enacted in July 2012. This act reauthorized/ authorized user fees for various submissions to ensure that the FDA is adequately funded for its mission. Another part of this act covers the supply chain.