by Mike Bennoson

Here is an overview of the pharmaceutical regulatory structure and GMP organization in Russia. Also below, details on the establishment of a National Pharmaceutical Inspection unit.

The National Pharmaceutical Inspection unit (NPI) was recently established. Plans are to recruit 60 inspectors from 2005 to 2006 for GMP, and eventually 200 to 300 inspectors for GDP. A General Director of the NPI has been appointed.

The Pharmaceutical Regulatory Structure is as follows:

• Ministry of Health - Legislation
• Federal Service - Russian healthcare supervision and control
• Federal Agency - Management of property

Federal Service has two areas, the Executive Branch (government policies and decision making) and Experts (pharmaceutical, medical devices and healthcare).

The Pharmaceutical Section employs experts who may be independent consultants and work on a contract basis.

This section has responsibility for:

• Registration of drugs
• GMP/GDP inspections through the NPI
• Clinical trials
• Laboratories
• Certification

Training of NPI inspectors is undertaken by both organizations, within and outside of Russia.

 

About the Author
Michael J. Bennoson joined ISPE in May 1996 and supports the European office in the development of European educational programs and ISPE links with regulatory authorities. Bennoson obtained a Bachelor of Technology degree in industrial chemistry from the University of Bradford, England. He emigrated to Montreal, Canada where he spent four years in quality assurance at Ayerst Laboratories. He then emigrated to New Zealand and established GMP inspections for the government as head of inspection for the Department of Health. Upon his return to the UK, he joined Wellcome (now GSK) in quality assurance, retiring as director of quality assurance operations, UK in December 1995. Bennoson was chairperson of the UK industry GMP Committee for 13 years and participated in a number of European working groups.