FOR IMMEDIATE RELEASE
Rockville, MD, July 29, 2019—The British Pharmacopeia (BP) and the United States Pharmacopeia (USP) formalized their long-standing partnership to strengthen the quality of medicines and improve public health around the world, in an agreement signed on Friday, July 26, at USP in Rockville, MD. Pharmacopoeial quality standards help drug manufacturers and regulatory agencies ensure medicines quality.
The formal Memorandum of Understanding establishes a framework for cooperative activities, including developing drug product monographs, information sharing, and expanding collaboration to new areas. The organizations intend to exchange scientific staff and participate in joint events.
"Modern innovations make this partnership essential to ensuring the quality of medicines," said Dr. Jaap Venema, USP executive vice president and chief science officer. "Our partnership helps both organizations develop standards that are used to protect the quality of the medicines patients worldwide take each and every day."
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. For more information about USP, visit www.usp.org.
The British Pharmacopoeia is a book of published and publicly available standardsi for pharmaceutical ingredients and finished medicinal products. It is prepared and published annually by the British Pharmacopoeia Commission, secretariat of the Medicines and Healthcare products Regulatory Agency of the United Kingdomii and is the only comprehensive collection of official standards for medicinal products. It provides an authoritative statement of quality that a medicinal product is expected to meet during its period of use to the end of its shelf-life.
iThe value of pharmacopoeial standards – These standards enable users to make an objective assessment in relation to the quality of a material. Where necessary these are supported by physical standards. Quality is critical to ensuring the safety and efficacy of medicines taken by patients every day. Pharmacopoeial quality standards are one of the foundations of ensuring acceptable quality alongside good practice quality guidelines and regulations and regulatory assessment.
iiMHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. Underpinning all our work lies robust and fact-based judgements to ensure that the benefits justify any risks. The MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The MHRA is an executive agency of the Department of Health.