USP partners with the Republic of Korea on laboratory testing of USP Reference Standard candidate materials

Ronald T. Piervincenzi and Dong Hee Lee
USP CEO Dr. Ronald T. Piervincenzi and NIFDS Director General Dr. Dong Hee Lee sign agreement on laboratory testing of USP Reference Standard candidate materials.

As part of USP’s External Laboratory Collaboration Program, USP and the National Institute of Food and Drug Safety Evaluation (NIFDS), part of the Republic of Korea’s Ministry of Food and Drug Safety (MFDS), signed an agreement on July 20, 2020 for collaborative testing of certain USP Reference Standard candidate materials. USP has had an ongoing collaboration with MFDS under a memorandum of understanding signed in 2012, which included activities such as pharmacopeial training, exchange of experts and symposia.

USP Reference Standards are an essential component in ensuring the quality of medicines and are used in more than 150 countries around the world. They are required for use in assays and tests in the official compendia, the United States Pharmacopeia–National Formulary (USP–NF), to ensure that medicines approved by the U.S. Food and Drug Administration meet specifications for identity, strength, quality, purity, and performance. USP’s External Laboratory Collaboration Program enables rigorous testing of USP Reference Standard candidate materials in qualified labs around the world to ensure their quality. This new partnership with NIFDS is expected to make an important contribution in USP’s continued work to help ensure manufacturers, scientists, healthcare practitioners and regulators deliver quality medicines and promote public health.

Learn more about the USP monograph and Reference Standard development process

About USP
USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. Through our standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and food for billions of people worldwide.