The Ministry of Health and Social Development is extremely interested in the transition of Russian pharmaceutical manufactures on the international quality standards GMP. This opinion was stated by Diana Mihailova the director of the Department of the pharmaceutical market and the market of medical equipment of  The Ministry of Health and Social Development in the annex "Pharmacy" to the newspaper "Kommersant". According to her, it is planned to join the Russian Federation to the International System of Pharmaceutical Inspection Cooperation (PIC / S), that will significantly reduce barriers for exports of high quality medicines for Russian manufacturers. "For the realisation of the state support to domestic producers the most popular health drugs there is a Federal program "The Development of pharmaceutical and medical industries for the period up to 2020». The first and crucial step in the forthcoming modernization should be  a training for personnel of manufactures and control of analytical laboratories but it does not imply a significant financial cost to the manufacturers»- Mihailova claimed.

The Association of Russian Pharmaceutical Manufacturers supports the state's interest in modernizing of the domestic pharmaceutical industry and the association is actively involved to the development of requirements for the transition of Russian producers on the world standard GMP. Draft guidelines developed by specialists of the enterprises members of the ARPM and experts in the field of drugs based on EU Directives were transferred to the Ministry for possible use in the preparation of national rules of the organization of production and quality control of medicines. Also members of the ARPH will participate in a global meeting with producers on the WHO prequalification that would be held on 26 and 27 June in Copenhagen. The meeting will provide an opportunity to hear from experts, inspectors and manufacturers about the general shortcomings in the records and quality systems (GMP, GCP) as well as about new or revised WHO guidelines. Main focus will be given to generic drugs, because innovative medicines are prequalified, mainly based on scientific assessment carried out by official regulatory agencies such as EMEA and U.S. FDA.

«It is encouraging that the state is interested in the modernization of the domestic pharmaceutical industry and it making every effort to do so. An important point was the interaction between business and government, which entered into a constructive dialogue. The Association has always been advocated for the transfer of Russian pharmaceutical producers in the world GMP standards. We were transferred to the Ministry draft regulations, which may become the basis for the establishment of the National GMP Regulations. With regard to training for work on international standards, members of the ARPM in the near future will participate in global meetings with producers, organized by the WHO European Regional Office, which will enable managers of domestic enterprises to get acquainted with the new GMP rules, to learn new and revised procedures and guidelines of WHO and to participate in the discussion on evaluating the dossier. The meeting also invited representatives of the regions of Russia, which announced to establish farmklasters in regions. All this will enable the domestic pharmaceutical industry to be ready to modernize industry, to increase the competence and authority of the Russian manufacturers»- the General Director Victor Dmitriev stated.

The Association of Russian Pharmaceutical Manufacturers represents the interests of Russian pharmaceutical manufacturers, and facilitates the competitive recovery of the domestic pharmaceutical industry. A key challenge is to assist Russian manufacturers in the changeover to the new GMP/ISO standards. 
www.arfp.ru