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Regulatory Focus™ > News Articles > 2019 > 7 > USP, British Pharmacopoeia Formalize Quality Standards Partnership

USP, British Pharmacopoeia Formalize Quality Standards Partnership

Posted 30 July 2019 | By Michael Mezher 

USP, British Pharmacopoeia Formalize Quality Standards Partnership

The US Pharmacopeia (USP) and its UK counterpart the British Pharmacopoeia (BP) on Friday signed a memorandum of understanding formalizing a partnership to strengthen quality standards for medicines.
While the two organizations are the officially recognized pharmacopeias in their respective countries, drugmakers often propose specifications in their applications based on quality standards from international pharmacopeias. In 2017, the US Food and Drug Administration (FDA) clarified when drug sponsors can propose specifications for excipients, drug substances and drug products based on standards from the BP, European Pharmacopoeia (EP) and the Japanese Pharmacopoeia (JP).
In 2012, USP and the BP announced the first two harmonized monographs for finish drug products based on an informal collaboration between the two pharmacopeias.
According to USP, the newly formalized agreement "establishes a framework for cooperative activities, including developing drug product monographs, information sharing, and expanding collaboration to new areas," and will enable the two organizations to exchange scientific staff and hold joint events.
"Modern innovations make this partnership essential to ensuring the quality of medicines. Our partnership helps both organizations develop standards that are used to protect the quality of the medicines patients worldwide take each and every day," said USP Chief Science Officer Jaap Venema.
James Pound, group manager for BP & laboratory services at the UK's Medicines and Healthcare products Regulatory Agency (MHRA) said, "The work we do will directly benefit from the knowledge sharing and collaboration that will result from this agreement. This will better enable us to serve the needs of our patients and stakeholders across the world and address the future challenges of assuring medicines quality."

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