Regulators Grow Global Presence
Table I: US Food and Drug Administration overseas staffing.
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As part of the US Food and Drug Administration's "Beyond our Borders" initiative, several new FDA offices are opening overseas
(see Table I). The highest number of FDA staff will be in India, where an increasing amount of regulated products are being
imported into the United States, according to the FDA press office. FDA plans to use its presence to conduct more inspections
in India and to work with other governments and private/public-sector entities interested in certifying that products from
India destined for the export market meet the highest standards for safety, quality, and purity. HHS officials are also developing
Memoranda of Understanding (MOU) with Belize, Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, Mexico,
Nicaragua, and Panama, according to the agency. (An MOU was signed with the Chinese State Food and Drug Administration [SFDA]
in late 2007.) The memoranda focus on product safety as well as potential information-sharing and joint training for inspections
(1).
FDA conducted 1479 inspections of foreign drug establishments between fiscal year (FY) 2002 and FY 2007 (2). The 10 most frequently
inspected countries during this period, in order, were: India, Germany, Italy, Canada, United Kingdom, China, France, Japan,
Switzerland, and Ireland. Ninety-four FDA inspections took place in China between FY 2002 and FY 2007; 199 took place in India.
The International Pharmaceutical Excipients Council (IPEC) and US Pharmacopeia (USP) are also expanding their presence abroad.
IPEC recently established a Chinese division to promote information-sharing. IPEC–China is also providing assistance to SFDA
to help revise draft excipient legislation that is better harmonized with international requirement, says IPEC–America's David
R. Schoneker. An IPEC–India, IPEC-Brazil and possibly an IPEC-Argentina division may be established in the future. Also on
the horizon is a possible IPEC federation to serve as an umbrella framework for the various global IPEC divisions.
In March 2008, the US Pharmacopeia (USP) signed an MOU with the Chinese Pharmacopoeia (CPH) that is similar to the FDA–SFDA
memorandum. The USPCPH memorandum focuses on four areas: building joint monographs, building relationships through scientific
exchange visits and joint research activities, translating the USP into Chinese (the last time the book was translated was
in 1923), and establishing a joint verification/certification program with the Chinese pharmacopoeia, according to Roger L.
Williams, USP executive vice-president and CEO. USP has had offices in China, as well as India, for a few years, and in August
2008, established a site in Brazil.
References
1. FDA, "Agreement between the Department of Health and Human Services of the USA and the State Food and Drug Administration
of the People's Republic of China on the Safety of Drugs and Medical Devices" (Rockville, MD), Dec. 11, 2007.
2. M. Crosse, "Statement, Subcommittee on Oversight and Investigations, House Committee on Energy and Commerce," Apr. 22,
2008.
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