Informal USP/BPC harmonisation

In an innovative and informal harmonisation endeavour, the US Pharmacopeial Convention (USP) and the British Pharmacopoeia Commission (BPC) developed two drug product quality standards that have been aligned in advance of inclusion in their respective compendia.

The two standards involved in the effort are for prescription eye drop medications: dorzolamide hydrochloride ophthalmic solution and dorzolamide hydrochloride-timolol maleate ophthalmic solution. The proposals are included in the May-June Pharmacopeial Forum (PF) 38(3). The proposals build on existing international harmonisation activities by extending efforts to finished drug products and by reconciling written standards, or monographs, in a prospective manner.

“Harmonisation has long been cited as an opportunity to promote public health through the advancement of consistent quality standards, recognising the modern drug supply is becoming increasingly globalised,” said Praveen Tyle, PhD, Executive Vice President and Chief Science Officer for USP. “It also may assist regulators, standards-setting bodies and pharmaceutical companies in saving resources, which may be redeployed for other initiatives.

Under this effort, we sought to explore how we can further cooperate with other pharmacopeias and potentially expand on existing harmonisation work. The informal nature of the activity, in which we simply traded information on monograph procedures, allowed us to work in a nimble way and may provide a model for future projects with BP and other groups.”

“In addition to harmonised standards, this collaboration may provide a new path to addressing some mutual challenges facing the BP, USP and other pharmacopeias, namely sharing resources to expedite the introduction of new monographs,” said Richard Turner, Principal Pharmacopoeial Scientist for the BP. “Given the success of this pilot project, we look forward to exploring future opportunities to strengthen both pharmacopeias.”

USP engages in formal trilateral harmonisation activities under the Pharmacopoeial Discussion Group (PDG) with representatives for the Japanese Pharmacopoeia (JP) and the European Pharmacopoeia (EP). This effort covers specific general chapters and excipient monographs that already exist in the three compendia. PDG is driven by a formal workplan.

Separately, USP and EP are engaged in a pilot project in which the groups are prospectively harmonising monographs for four active pharmaceutical ingredients (drug substances). However, EP encompasses only drug substances and not finished drug products. Both BP and USP encompass both drug substances and drug products, supporting the new, informal approach.

The draft standards took one year to reach the current proposal status - a relatively short timeframe for a harmonisation activity. The harmonisation is with respect to the analytical procedures only, and was initiated and conducted in cooperation with the sponsor of the monographs.

To view the proposals, please see http://www.usp.org/usp-nf/pharmacopeial-forum (please note one-time registration is required, but is free for all parties).