USP and British counterpart join forces

Published: 31-Jul-2019

Pharmacopoeias in the US and in the UK have signed a memorandum of understanding to strengthen quality standards for medicines

The US Pharmacopeia (USP) and its UK counterpart, the British Pharmacopoeia (BP), have signed a memorandum of understanding formalising a partnership to strengthen quality standards for medicines, the Regulatory Affairs Professionals Society (RAPS) has reported.

While the two organisations are the officially recognised pharmacopoeias in their respective countries, drugmakers often propose specifications in their applications based on quality standards from international pharmacopoeias.

"Modern innovations make this partnership essential to ensuring the quality of medicines. Our partnership helps both organisations develop standards that are used to protect the quality of the medicines patients worldwide take each and every day," said Jaap Venema, USP Chief Science Officer.

Pharmacopoeia harmonisation

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 harmonised monographs for finish drug products based on an informal collaboration between the two pharmacopoeias.

According to USP, the newly formalised 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.

James Pound, group manager for BP & laboratory services at the UK's Medicines and Healthcare products Regulatory Agency (MHRA), commented: "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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