Key Global Facts

Drugs
 80% of API manufacturers are located outside the United States
 At least 40% of drugs on U.S. shelves come from overseas.
 Pharmaceutical product imports increased at nearly 13% per year from 2005-2011


Challenges presented by globalization
• More dispersed facilities supplying global market
• Increasing volume of imported products
• More outsourcing of manufacturing
• Greater complexity in supply chains
• Imports coming from countries with less developed
regulatory systems
• Greater opportunities for economic fraud

Things FDA is doing


Partner with foreign counterparts to
create global coalitions of regulators
focused on ensuring and improving
global product safety
 Build global data-information systems
and networks and proactively share data
with peers
 Expand intelligence gathering, with an
increased focus on risk analytics and
thoroughly modernized IT capabilities
 Effectively allocate agency resources
based on risk, leveraging the combined
efforts of government, industry and
public and private third parties

facts obtained from FDA here