USP Forms Collaboration with Russia - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

USP Forms Collaboration with Russia


ePT--the Electronic Newsletter of Pharmaceutical Technology

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.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
31%
Breakthrough designations
8%
Protecting the supply chain
42%
Expedited reviews of drug submissions
8%
More stakeholder involvement
12%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here