Eastern Europe

Over the past few years, USP has expanded its activities in Eastern Europe. A key focus has been collaborating with regional governments on standards development and translation work. USP works with the Russian Federation to improve medicine quality in several ways, including its USAID–funded Promoting the Quality of Medicines (PQM) program.

Collaborations

Memorandum of Understanding (MOU)

In April 2009, USP formalized and expanded its work in the Russian Federation with an MOU with the  Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor) of the Russian Federation. The MOU has fostered the exchange of information and scientific personnel, with the translation of USP–NF into the Russian language as a key component for further interactions.

Adopt/Adapt Agreements

• In 2010, USP entered into an agreement with the Ukraine Scientific Pharmacopoeial Centre for the Quality of Medicines (the Centre) that provides a five-year, renewable right to include written standards from the USP–NF in the Ukraine Pharmacopoeia and its companion journal, Pharmacom. The standards may either be included entirely as they are published in the USP–NF, in translation (“adopted”) or modified to better suit the Centre’s requirements for the Ukraine (“adapted”).
• A similar adopt/adapt agreement was signed in October 2010 with Kazakhstan’s Republican State Enterprise National Centre for Expertise of Drugs, Medical Products, and Equipment of the Ministry of Health.

Translations

In 2009, the USP–NF Russian translation was published and introduced at the XVI Russian Man and Drug National Congress. The translation was completed by GEOTAR-MEDIA, who also distributes the publication online. A bridge extension was created in 2011 to advance work on updating the Russian translation so that it is more current with the English edition. Learn more about the USP–NF Russian edition.

Events

• In April 2011, through PQM (the USP–USAID collaborative program), USP held Workshops for second-line anti-TB medicine manufacturers in Moscow and the Ukraine. The sessions focused on the WHO Prequalification Programme, obtaining technical assistance for prequalification, and GMPs.
• In June 2011, through PQM, USP hosted a study tour by key officials from Roszdravnadzor's drug control laboratory system—including discussions with the US FDA and others.
• Also through PQM, USP teamed up with Roszdravnadzor in 2010 to offer USP’s Pharmacopeial Education courses to technical staff of drug quality control laboratories in the Russian Federation. Learn more about these events.
• USP staff participated in the international Roszdravnadzor meeting on “Standardization of Medicines and Harmonization of Requirements.”

Convention & Volunteer Representation

These Eastern European countries have members and/or observers to the U.S. Pharmacopeial Convention, and/or citizens who serve as USP Expert Volunteers. [KEY: M–Members, O–Observers, EV–Expert Volunteers]

• Kazakhstan (M)
• Russian Federation (M, O)
• Ukraine (M, O)