Evaluating the Pieces of the Pharma Supply Chain - Pharmaceutical Technology

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Evaluating the Pieces of the Pharma Supply Chain
After a year of increased attention on the pharmaceutical supply chain in Asia, what will be the region's short- and long-term role? This article contains bonus online-exclusive material.

Pharmaceutical Technology
Volume 33, Issue 1

Regulators Grow Global Presence

Table I: US Food and Drug Administration overseas staffing.
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.


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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