Remarks at US-China Pharmacopeia Joint Symposium in Hangzhou, China Highlight Challenges and Ways Forward

With patients and consumers around the world depending on the world's medicines- and food-standards setting bodies to develop robust standards, technical and resource challenges mean that these pharmacopeial organizations must work together more closely than ever before, said Roger L. Williams, M.D., chief executive officer of the United States Pharmacopeial Convention (USP). Williams spoke today to more than 600 participants at the 4th Joint International Symposium cosponsored by USP and the Chinese Pharmacopoeia Commission (ChP) in Hangzhou, China.

"All of the world's pharmacopeias face a variety-and growing number-of technical issues as they try to develop and adopt the kinds of standards that drug regulators, manufacturers, and patients and consumers depend upon to assure quality and safety. They also are all resource-constrained," Williams said. "There is strength in numbers if we work together more closely. We have an obligation to do that if we are going to meet these urgent public health needs around the globe," he added.

USP increasingly has been active around the world working with those organizations. In his remarks at the joint symposium, Williams reviewed activities with Chinese organizations, which include:

    -- Memoranda of Understanding (MOUs ) with: ChP, the National Institutes

       for Food and Drug Control (NIFDC), the National Institute for Nutrition

       and Food Safety, and four provincial drug and food control agencies

       (Shanghai, Zhejiang, Beijing, and Guangzhou)

    -- Membership of eight prominent experts from China in USP's

       standards-setting committees

    -- Participation by multiple technical staff annually in USP's Visiting

       Scientist program

    -- Translation of USP's standards into Mandarin

    -- Joint laboratory work leading to the production of USP's reference

       standards, used worldwide by manufacturers and regulatory authorities

       to help assure the quality of drugs and foods

Wu Zhen, deputy commissioner of the State Food and Drug Administration (SFDA) and secretary general of ChP, set out the variety of challenges facing China as it seeks to improve the quality of medicines. Noting the critical importance of pharmacopeial standards, he described an ambitious program underway to advance those standards. Wu stres