USP Forms Collaboration with Russia

Apr 15, 2009

The United States Pharmacopeial (USP) Convention signed a memorandum of understanding (MOU) with the Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (Roszdravnadzor) last week in Moscow. Roszdravnadzor is the surveillance agency for medicines and medical supplies within Russia’s Ministry of Healthcare and Social Development.

Under the MOU, USP is collaborating with Roszdravnadzor for the first Russian translation of USP’s United States Pharmacopeia–National Formulary (USP–NF), which USP introduced last week at the XVI Russian Man and Drug National Congress. The Russian version of the compendia was translated and published by Geotar–Media, a publishing company in the Russian Federation known for its translations of medical works.

USP plans to publish a supplement to the book in 2010. At this time, the translation is current through USP 29 and NF 24, with ongoing plans to make the translation current.

Other potential areas of collaboration between the two groups under the MOU include:

  • Working relationships: Activities such as organizing joint annual scientific meetings, exchanging scientific staff, promoting pharmacopeial harmonization, promoting the use of modern laboratory standards and application of modern metrologic principles, and facilitating the exchange of information and taking action in cases of emergencies arising from accidental contamination or intentional adulteration of medicines and their ingredients
  • Reference materials: Development and use of reference materials for ensuring compliance to procedures described in compendia, including the USP–NF.
  • Third-party certification: Establishment of programs that
    allow review, testing, and auditing of manufacturers of pharmaceutical ingredients that are available in either the US or the Russian markets.