USP and Chinese Pharmacopeia Extend Partnership to Improve Medicines Quality and Patient Safety


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Agreement reflects 26-year history of working together during increasing globalization of drug manufacturing and delivery

October 27, 2016, Rockville, Md. — The United States Pharmacopeial Convention (USP) and the Chinese Pharmacopoeial Commission (ChP) recently renewed a Memorandum of Understanding (MOU) on October 19 that reaffirms their commitment to work together, and furthers a historic partnership forged to improve public health.

USP CEO Ron Piervincenzi, Ph.D., and ChP Secretary-General, Mr. Wei Zhang, signed the agreement, which establishes a framework for their cooperative engagement over the next three years. The partners agreed to collaborate to strengthen pharmacopeial standards as a means of assuring better patient and consumer care in China and the United States (U.S.).

“The USP and Chinese Pharmacopoeia share a common goal of improving the quality and safety of medicines in the global supply chain, and creating positive synergies among all of the world’s pharmacopoeias to improve public health,” Dr. Piervincenzi said. “This renewed commitment between the organizations builds on our deep commitment to quality.”

Mr. Wei Zhang, ChP’s Secretary-General, added that this agreement signifies a new era of collaboration between the organizations. 

“The partnership between ChP and USP is an example of the type of multilateral cooperation that is needed to overcome the challenges of globalization,” Zhang said.

“We have made great strides in standards development with the release of the 2015 Edition of the Chinese Pharmacopeia, and are confident that through this partnership we will continue to improve the standards we set,” he said.

Since USP’s first visit to ChP in 1990, the organizations have established a strong and mutually beneficial relationship for cooperation and exchange. In 2005, an initial agreement between the partners was signed, which solidified the relationship and laid the foundation for long-term cooperation.

Under this revised agreement, the two partners will intensify efforts to strengthen standards in respective pharmacopoeias, collaborate at the leadership level, exchange standards information and scientific personnel, and participate in joint standard-setting and harmonization activities.

To kick-off their renewed partnership, the pharmacopeias jointly hosted a workshop at USP, during which delegates from both organizations shared perspectives and priorities in standards development with participants from the pharmaceutical industry and regulatory agencies.

Jaap Venema, Ph.D., USP’s Chief Scientific Officer shared USP’s plans to ensure its standards are updated by 2020. He also discussed USP’s work in both the United States and around the world, as well as how the non-profit is working to engage and shape the broader ecosystems in which quality systems exist.

“Quality standards for drugs must undergo continuous revision, or modernization, in order to reflect ‘state-of-industry’ practices at any given time,” Dr. Venema told the audience.

“USP is investing substantial resources into accelerating the pace of development to ensure our standards are current, suitable for their intended use, and accessible globally.”

Like Zhang, Dr. Venema believes collaboration among international standards-setting organizations greatly facilitates and expedites standards development and international harmonization.

Delegates of the pharmacopoeias discussed developing harmonized, up-to-date global quality standards for high-impact excipients as a tangible area of cooperative effort given the important role these products play in the global supply chain.

“Globalization may be challenging—and making less clear—traditional roles, definitions and ways of working within the pharmaceutical and international regulatory industries,” Dr. Piervincenzi said. “But as standard-setting organizations, these are challenges that, together with our partners, we’re excited to meet.”

Despite the complexity that globalization has created for organizations responsible for ensuring the quality and safety of medicines, science-based standards will continue to play a vital role in advancing quality, he said.

The partners expect their collaboration to encourage other organizations to join them in advancing the quality agenda in ways that help pharmaceutical manufacturers respond to patient needs, regulators establish quality assurance systems, and practitioners and patients maintain trust and confidence in drug therapies.

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