USP and NICPBP Sign Memorandum of Understanding

The US Pharmacopeial Convention (USP) and the National Institute for the Control of Pharmaceutical Biological Products (NICPBP), China’s agency for overseeing the quality of large- and small-molecule drugs, signed a memorandum of understanding (MOU) to bolster the quality of medicines in China and in the countries that buy Chinese drug products, including the United States.

Roger L. Williams, USP’s chief executive officer, and Yunlong Li, director general of NICPBP, signed the MOU at USP’s headquarters in Rockville, Maryland. A delegation of representatives from the NICPBP and other Chinese drug-control bodies accompanied Li at the signing.

“This partnership with NICPBP is an important step in helping to assure that the best quality medicines are reaching patients, which is crucial to advancing public health in China, and in the many countries around the world to which China exports medicines, including the United States,” said Williams in a USP press release.

“The NICPBP looks forward to a continuing relationship with USP as we share our scientific expertise and work collaboratively to ultimately improve the global drug supply,” said Li in the USP press release.

USP and NICPBP say the MOU will heighten awareness of the importance of quality medicines and identify areas of mutual interest and potential collaboration. The MOU identified the following potential areas of collaboration:

• Collaborative testing of physical reference standards for drugs

• Exchange of scientific staff and expertise

• Development and validation of analytical procedures and technology

• Collaboration on projects such as methods and techniques for detecting counterfeit and substandard drugs

• Quality control of biotechnology products.

NICPBP has been a member of the USP Convention since April 2008, when Li was appointed as the first representative from China. NICPBP prepares and distributes Chinese national standards, conducts postmarket quality surveillance of drugs, and prepares, calibrates, preserves, and distributes physical reference standards in China. USP sets federally recognized standards for the identity, quality, purity, and strength of prescription and over-the-counter medications sold in the US.