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Regulatory Focus™ > News Articles > US, British Pharmacopoeias Tout Effort to Harmonize Drug Standards

US, British Pharmacopoeias Tout Effort to Harmonize Drug Standards

Posted 15 May 2012 | By

The US Pharmacopoeia (USP) and the British Pharmacopoeia (BP) have announced the harmonization of two drug product quality standards for two eye drop medications-a first for the two groups and an effort that could lead to more cooperation between the two groups in the future.

The newly-harmonized standards cover dorzolamide hydrochloride ophthalmic solution and dorzolamide hydrochloride-timolol maleate ophthalmic solution, and are included in the Pharmacopeial Forum 38(3).

The groups noted the development of the standard took only one year to become finalized-a relatively short timeframe for a harmonization activity."

"Under this effort, we sought to explore how we can further cooperate with other pharmacopeias and potentially expand upon existing harmonization work," said Praveen Tyle, Ph.D., executive vice president and chief science officer for USP. "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."

The groups said the close levels of cooperation is likely to lead to further harmonization efforts in the near future, particularly as it relates to sharing resources.

"Given the success of this pilot project, we look forward to exploring future opportunities to strengthen both pharmacopeias," said Richard Turner, principal pharmacopoeial scientist for the BP.

Read more:

U.S., British Pharmacopeias Collaborate on Newly Proposed Standards, Help Advance Consistent Quality Expectations for Medicines Across Borders

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