USA – 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…