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USP and Russia Make Headway on Improving Drug Quality

In April 2009, the US Pharmacopeial Convention (USP) and the Russian Federation’s regulatory agency, Roszdravnadzor, signed a memorandum of understanding to work toward protecting and improving the quality of medicines worldwide.

Last week, USP and the Ukraine Scientific Pharmacopoeial Centre for the Quality of Medicines agreed to share standards for the quality, purity, strength, and identity of medicines.

The Ukrainian center will have a five-year, renewable right to include written standards (as written or modified) from the US Pharmacopeia–National Formulary (USP–NF) in its own pharmacopoeia and companion journal, Pharmacom.

“This agreement is a milestone in helping to promote public health internationally. The scientific exchange represented by the agreement with the Centre will benefit not only the citizens of the Ukraine, but also Ukrainian manufacturers wishing to export to other countries,” said USP chief executive officer Roger Williams in a press release. “USP will benefit from the experience of the Centre’s scientists, which in turn contributes to the strength of the standards published in the USP–NF.”

The Ukrainian center also will explore opportunities to use USP’s accompanying reference standards to help evaluate drug quality and identity, according to the release.

Also last week, USP announced that it had completed a series of eight drug quality courses at Moscow’s Scientific Center for Expertise of Medical Products as part of ongoing collaborative efforts.

The original MOU from April 2009 called for USP and Roszdravnadzor to increase working relationships by exchanging scientific staff, facilitating the exchange of information, developing and using reference materials, and establishing third-party certification programs to allow for the review, testing, and auditing of drug manufacturers in the two countries.


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