USP Partners Globally for 21st-Century Medicines - Pharmaceutical Technology

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USP Partners Globally for 21st-Century Medicines
USP focuses on building worldwide partnerships in standards-setting activities.

Pharmaceutical Technology
Volume 37, Issue 7, pp. 36-37

A shared vision
While ongoing information exchange has helped shape relationships between USP and its international counterparts, other activities have also helped to strengthen ties. Through the Joint ChP-USP Executive Training Program, USP and ChP have developed a means of introducing USP's standards-setting process to leaders from quality-control laboratories of provincial institutes responsible for China's standards and regulations. Not only does the program inform Chinese pharmacopoeial and regulatory leaders about USP, it also serves as a forum for USP to learn about the challenges faced by its Chinese counterparts. Since the program's inception in 2006, more than 100 representatives from Chinese governmental bodies have completed the training.

In June 2013, USP hosted its second International Training Program (ITP) with representatives from 17 international regulatory and enforcement agencies and national reference laboratories. Participants were invited to learn about USP and its standard-setting activities for chemical and biological medicines as well as foods, dietary supplements, and herbal medicines. Delegations from countries in the Middle East, Africa, Russia, and the former Soviet republics spent two weeks at USP headquarters in Rockville, Maryland for the program, with another delegation from Latin America scheduled to participate in the ITP in August 2013.

Another way in which USP has worked more closely with other nations has been through the Visiting Scientist Program. Through this program, scientists from pharmacopoeias and regulatory agencies in other nations conduct multimonth projects at USPRockville, working side-by-side with USP scientists to help advance specific standards-setting goals in small molecules, biologics, and food ingredients. This program has had visiting scientists participate from China, Russia, Brazil, Vietnam, the Ukraine, Nigeria, Thailand, Argentina, Egypt, Jordan, Myanmar, and other nations.

USP's standards-setting activities are driven by the work of its volunteer body, the USP Council of Experts (CoE). In 2011, USP launched the new Medicines Compendium (MC)—a free online resource providing public standards for medicines approved in any country. The first USP Expert Committee established in support of the Medicines Compendium was based in India, followed by a second MC Expert Committee established in China. Today, Expert Committees for the MC are based in South Asia, East Asia, and Latin America with a fourth global Expert Committee that consists of experts on biologics.

USP's presence around the world
In fewer than five years, USP's growth has included new laboratory facilities at USP's Rockville location and at its international sites in India, China, and Brazil. USPIndia in Hyderabad has state-of-the-art chemical, biological, and microbiological laboratories dedicated to collaborative testing of USP reference standards and analytical procedure development in support of the creation of public standards. Currently, USP's 10,000-ft2. Shanghai site is undergoing an expansion. By early 2014, USP will inaugurate its new 100,000-ft2. facility, two-thirds of which will be dedicated to expanded laboratory capabilities that will support USP's monograph modernization initiatives as well as USP activities related to food ingredients, dietary supplements, and USP's newest compendium, the Herbal Medicines Compendium. Similarly, USPBrazil is focused on supporting the activities of several USP compendia of standards, including USP–NF and MC. For more information about USP's growing international partnerships, go to:

V. Srini Srinivasan, PhD, is executive vice-president of global science and standards & chief science officer, US Pharmacopeial Convention.


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