Navigation Links
US, Russian organizations team to improve the quality of medicines

Rockville, Md., April 7, 2009 Aiming to improve the quality of medicines in the Russian Federation and the United States, two leading drug quality organizations in those countries today announced plans to work together on standards-related activities for drugs and their ingredients. These include efforts to reduce the availability of counterfeit and substandard medicines.

The agreement was captured in a Memorandum of Understanding (MOU) signed in Moscow by the Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (Roszdravnadzor) and the United States Pharmacopeial (USP) Convention. Roszdravnadzor is the surveillance agency for medicines and medical supplies within Russia's Ministry of Healthcare and Social Development. USP is an independent, non-profit organization that sets federally recognized quality standards in the United States for prescription and over-the-counter medications. It also sets widely recognized standards for food ingredients and dietary supplements.

"Access to good quality medicines is of critical importance to the public health, given the role that medicines play in saving lives, restoring health, and treating and preventing diseases," said Roger L. Williams, M.D., chief executive officer of USP. "Through a number of potential activities detailed in this agreement, Roszdravnadzor and USP will work to improve the quality of medicines that patients receive in Russia and the United States. This includes reducing the availability of counterfeit and substandard medicines, which pose a substantial threat to citizens of both countries and globally."

"With medicines and their ingredients coming from all over the world, international collaboration is a key part of protecting and enhancing the health of patients," said N.V. Yurgel, head of Roszdravnadzor. "We look forward to a productive relationship with USP that ultimately results in a safer drug supply."

Among the potential areas of collaboration is utilization of the first Russian translation of USP's internationally recognized book of drug standards, the United States PharmacopeiaNational Formulary (USPNF), which USP is introducing this week at the XVI Russian Man and Drug National Congress. Through these compendia, USP provides scientifically based standards that help ensure the identity, quality, purity and strength of more than 4,000 medicines, drug substances, dosage forms, excipients (inactive substances such as binders, coatings, colorings, flavorings, preservatives and sweeteners), and dietary supplements. The Russian version of the compendia was translated and published by GEOTAR-MEDIA, one of the leading publishing companies in the Russian Federation and well known internationally for its translations of major 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 plans on-going to make the translation current.

"As USPNF is the world's most complete collection of quality standards for medicines, I believe that its translation into Russian will promote further enhancement of Russia's regulatory system for medicines, harmonization of Russian pharmacopeial standards with those of the world's leading pharmacopeias and improvement of drug quality in Russia as a whole," said Yurgel.

Other potential areas of collaboration between the two groups as detailed in 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 exchange of information and taking action in cases of emergency arising from accidental contamination or intentional adulteration of medicines and their ingredients will be considered.
  • Reference Materials. Development and use of reference materials, which are essential for assuring compliance to procedures described in compendia including the USPNF, is another possible activity.
  • Third-Party Certification (Verification). Establishment of programs that allow review, testing and auditing of manufacturers of pharmaceutical ingredients available in either the United States or the Russian markets will be considered.


Contact: Francine Pierson
US Pharmacopeia

Related medicine news :

1. Partnership to Prevent HIV Among Vulnerable Russian Youth
2. Movement Against Cancer, a Cancer Patient Advocacy Group in Russia, Launches an Effort to Inform Russian Authorities and the Public About Inadequate Access of Innovative and Effective Cancer Treatments for Cancer Patients in Russia
3. Number of Russian women smokers has doubled since Soviet collapse
4. Leading Russian Cancer Center Acquires CyberKnife(R) System
5. Russian research for FAIR
6. AIDS Organizations Support New HIV Testing Bill
7. Joplin Citizens and Health Organizations Call on Missouri Gov. Nixon for Study, Action on High Incidence of Birth Defects and Chronic Diseases in Community
8. Leading Healthcare Organizations Share Successes Realized with MEDais Predictive Analytics
9. Miami-Dade and Monroe County Organizations Receive Grants to JumpStart the Conversation
10. Komen Tulsa Affiliate Awards $420,000 to Local Organizations to Aid Breast Cancer Fight
11. Independent Review Organizations Take Pressure Off Healthcare Payers as Recession Deepens
Post Your Comments:
(Date:11/25/2015)... ... November 25, 2015 , ... Brillianteen, ... friendships, and learning in its 65th Anniversary Brillianteen Revue, scheduled for March 4-6, ... , For 65 years, Brillianteen has been a treasured tradition for numerous families ...
(Date:11/25/2015)... ... November 25, 2015 , ... Castlewood Treatment Center for Eating ... disorders as a result of the $20,000 raised at the center’s recent ... Golf Club in Eureka, will help individuals who otherwise might not seek treatment ...
(Date:11/25/2015)... ... November 25, 2015 , ... An unlikely ... resulting in a way for homeless people to have a more dignified and ... new initiative whereby they are repurposing plastic bags into sleeping mats for the ...
(Date:11/25/2015)... ... November 25, 2015 , ... Students and parents have something to be thankful ... Create Real Impact awards. California Casualty is proud to support the contest ... distracted and reckless driving, the number one killer of young drivers. , Almost ...
(Date:11/24/2015)... , ... November 24, 2015 , ... Dr. Todd S. ... offer laser services to many of his patients. Dr. Afferica now uses the BIOLASE ... reduce the amount of time the doctor uses other traditional cutting tools, such as ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)... , Nov. 25, 2015  ARKRAY USA ... continues to provide evidence demonstrating the accuracy of its ... Congress on Insulin Resistance, Diabetes and Cardiovascular Disease in ... both the Company,s GLUCOCARD ® 01 meter and ... accuracy requirements. The ability to accurately measure glucose levels ...
(Date:11/25/2015)... 2015  Trovagene, Inc. (NASDAQ: TROV ), a ... Executive Officer Antonius Schuh, Ph.D., is scheduled to present ... Piper Jaffray Healthcare Conference. th Annual ... Hotel in New York on ... Schuh will be available for one-on-one meetings during the ...
(Date:11/25/2015)... , Nov. 25, 2015 USP ... hazardous drug preparations (e.g. pharmacists, pharmacy technicians, nurses, ... veterinary technicians). The chapter also covers all entities ... (e.g., pharmacies, hospitals, other healthcare institutions, patient treatment ... --> --> What ...
Breaking Medicine Technology: