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Patricia Van Arnum was executive editor of Pharmaceutical Technology
A new report by FDA details the strategies, programs, and other activities the agency is using to address the rise of imported pharmaceutical products and APIs.
FDA issued a new report this week that details the activities that the agency is using to address the increased globalization of the industries that it regulates, including pharmaceuticals.
“As our world transforms and becomes increasingly globalized, we must come together in new, unprecedented, even unexpected, ways to build a public health safety net for consumers around the world,” said FDA Commissioner Margaret A. Hamburg, MD, in an Apr. 23, 2012, FDA press release.
Since 2002, imports of pharmaceuticals products and biologics have more than doubled, according to the FDA report, Global Engagement. Foreign-sourced pharmaceuticals now account for approximately 40% of the drugs consumed in the United States, and 80% of APIs in US-consumed drugs are sourced from abroad.
The report outlines a variety of engagement strategies FDA is using in partnership with other agencies, organizations, and coalitions around the world to strengthen global regulatory capacity-building efforts, develop and harmonize science-based regulatory standards, increase awareness about the importance of regulatory systems, and share information and data globally to facilitate rapid identification of and response to public health emergencies.
Part of FDA’s strategy has been to open international offices to increase the agency’s overseas presence. As of 2011, FDA has posts in China (Beijing, Shanghai, and Guangzhou), India (New Delhi and Mumbai), Latin America (San Jose, Costa Rica; Santiago, Chile; and Mexico City, Mexico), Europe (Brussels, London, and Parma, Italy), South Africa (Pretoria), and the Middle East and North Africa (Amman, Jordan).