USP and NIBSC to collaborate on improved quality standards for biological...( Rockville Md. December 18 2008 To i...),Health

Rockville, Md., December 18, 2008 To improve the quality of the rapidly expanding array of biological medicines, the U.S. Pharmacopeial (USP) Convention has entered into a Memorandum of Understanding (MOU) with the National Biological Standards Board, which manages the National Institute for Biological Standards and Control (NIBSC) of the United Kingdom. Biological medicines are made with materials derived from plants or animals, rather than those created in a chemical laboratory. The MOU will help improve and harmonize quality standards for these medications.

"USP is dedicated to improving the health of people around the world through public standards that help ensure the quality, safety and benefit of medicines and foods," said Roger L. Williams, M.D., executive vice president and CEO of USP. "This collaboration with NIBSC is another step in establishing critical partnerships to develop the best quality standards for biological medications as well as for traditional pharmaceuticals."

Specifically, USP and NIBSC are considering the following collaborative activities:

• Preparation of reference materials for biological products at NIBSC and in USP laboratories;
• Preparation of reference materials for biologics that are linked with pharmacopeial documentary standards;
• Collaborative research agreements leading to joint publications and compendial methods; and
• Mutual availability of scientists to serve and support each organization's committees, education or training programs and meetings.

USP and NIBSC play key roles in the development, characterization and dissemination of reference materials and documentary standards for medicines. Biological materials are an increasingly important means of preventing and treating illness, restoring health and saving livesand this MOU will advance public health through collaboration on improved quality standards for these medicines.

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