USP Partners Globally for 21st-Century Medicines

As segments of the global pharmaceutical market continue to cross and converge across national and regional borders, manufacturers of APIs, raw materials, and finished drug products throughout the world find themselves needing to comply with differing regulatory demands. Manufacturers have to balance requirements set forth by the more codified regulatory environments of the US and Europe while contending with the rapidly transforming nature of other healthcare markets such as China or India. Differences in regulatory systems are based on several factors, including healthcare priorities as well as specifications for product quality that differ from country to country. These regulatory complexities can create additional challenges for the manufacturer in attaining the ultimate goal of providing good quality medicines to patients worldwide.

V. Srini Srinivasan

A nonprofit scientific organization, the US Pharmacopeial Convention (USP) establishes standards in various compendia for the identity, strength, quality, and purity of medicines and their ingredients. Under US federal law, standards published in the United States Pharmacopeia and the National Formulary (USP–NF) are enforceable by FDA for products manufactured or marketed within or imported to the US. As systems for global pharmaceutical manufacturing, distribution and regulation increase in complexity and as FDA increases its inspections of manufacturing sites outside of the US, USP's standards-setting activities are becoming increasingly focused on relationships built with partners worldwide.

Communicating through scientific exchange

During the course of the past decade, USP has made great progress in strengthening its ties with ministerial and regulatory bodies responsible for the regulation of medicines in China, India, Brazil, and other parts of the world. A key driver for building these relationships has been the ongoing exchange of information and knowledge on public standards for medicines, dietary supplements, and food that undergird the regulatory framework for each country.

On Sept. 18-19, 2013, USP and the Chinese Pharmacopoeial Commission (ChP) will cohost the 10th Annual USP Science and Standards Symposium in Baltimore, Maryland, in partnership with the Drug Information Association (DIA). The symposium will be the sixth in a series of annual joint meetings cohosted by USP and ChP. With the theme "Partnering Globally for 21st Century Medicines," the symposium will focus on regulatory and compendial topics relevant to the manufacture of chemical and biological medicines, herbal medicines, and excipients.

Setting the stage for the two-day symposium will be keynote presentations by thought leaders invited from the China Food and Drug Administration (CFDA), the National Institutes of Health, FDA, and global pharmaceutical manufacturers. Speakers will share insights on the role that modern medicines play in healthcare systems and healthcare delivery in both China and the US. Mechanisms to promote the availability of good-quality modern medicines and that help ensure patient and consumer access will be addressed with a focus on both challenges and opportunities. Invited speakers include Wang Lifeng, director general of drug registration at CFDA; Roger Williams, PhD, chief executive officer of USP; Wang Ping, deputy director general of ChP, and representatives from FDA.

On day one of the symposium, general sessions will highlight industrial, regulatory, and pharmacopeial perspectives on the manufacturing areas aforementioned. The second day will offer presentations by experts from industry, USP, and ChP on subjects such as:

• Monograph and reference standard development practices—perspectives from ChP and USP

• Elemental and organic impurities control in the USP–NF as well as the Chinese Pharmacopoeia

• Assay transitions in biological medicines

• Defining excipient quality and reporting on modernization and harmonization of excipient standards

• Advances in and international perspectives on traditional medicines

• Legacy biologic products and naturally derived materials—raising the analytical bar.

Immediately following the symposium, USP will host the Global Summit of the Pharmacopoeias. This event will convene representatives of pharmacopoeias invited from multiple countries such as India, Brazil, China, Vietnam, and others and provide a forum for exchange about areas of shared interest and potential collaborations. Registration information and a symposium agenda can be found at http://uspgo.to/S3-Baltimore.

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 USP–Rockville, 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. USP–India 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, USP–Brazil 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: http://www.usp.org/around-world.

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