USP Collaborates with Asian Authorities

This week, the US Pharmacopeial (USP) Convention and the Vietnamese Pharmacopoeia Commission (VPC) signed a memorandum of understanding (MOU) that will help ensure the safety of Vietnamese medicines. The MOU establishes a partnership between USP and VPC that will encompass activities such as developing new and updated written standards, testing both agencies’ potential reference standards, scientist-exchange programs, joint participation in planning and policy meetings, and identifying joint projects to improve drug quality.

“I am delighted to work with colleagues here in Vietnam and elsewhere in Asia to help ensure the quality of medicines around the world,” said Roger L. Williams, USP’s CEO, during a signing ceremony at the Institute of Drug Quality Control in Ho Chi Minh City, according to a USP press release.

“Vietnamese regulators and manufacturers look forward to working closely with USP to reach our shared goal of good-quality medications,” said Nguyen Van Tuu, chairman of the VPC, according to the press release.

The MOU with the VPC is the latest example of USP’s recent focus on ensuring the quality of drug products in Asia. Last week, USP signed an MOU with nine member countries of the Association of Southeast Asian Nations (ASEAN). The agreement includes areas of potential collaboration such as establishing measurement standards for medicines that are consistent with those of the World Health Organization and the International Organization for Standardization (ISO), promoting ISO certification for ASEAN drug-quality control laboratories, support for joint studies and scientist-exchange programs, and the development of ways to combat counterfeit and substandard medicines.

ASEAN’s agreement with USP results from discussions about improving the production and quality of ASEAN Reference Substances that began in 2008. Regulatory officials from Cambodia, Laos, Myanmar, Singapore, Vietnam, Indonesia, Malaysia, the Philippines, and Thailand formed an ASEAN Reference Substances Working Group to focus on modern, international measurement standards for medicines in the region.

In addition, USP reached three new cooperative agreements with Chinese drug-control authorities on June 19, 2009, including MOUs with the Beijing Municipal Institute of Drug Control and the Zhejiang Institute for Food and Drug Control. The agreements aim to strengthen the agencies’ relationships through scientist-exchange programs, joint standards- and testing-related work, and projects to improve drug quality.

As a result of a 2008 agreement, USP and the Chinese Pharmacopoeia Commission agreed to jointly develop standards for active pharmaceutical ingredients that the US Food and Drug Administration and the China State Food and Drug Administration say are especially important for patients and physicians. Chinese manufacturers supply ingredients to international pharmaceutical manufacturers, and these agreements reflect the parties’ commitment to ensuring that quality concerns are addressed.

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