Russian Roszdravnadzor and Ministry of Health participate in international medicinal products development actively
Harmonization is essential for pharmaceutical industry. Basic players capture the market which results into globalization. Expansion happens in all countries, not only in countries these companies originate from. Regulatory revolution reflects market trends nowadays. Nine out of ten pharmaceutical companies that have the highest market share in Russia are foreign, according to published data for Dec 2016 and Jan 2017. Consequently, governmental expert organizations in Russia cooperate close with international organizations.
World Health Organization (WHO) offered to Centre of Pharmacopoeia and International Cooperation, a subdivision of Russian Scientific Centre for Expert Evaluation of Medicinal Products’ (“SCEEMP”) to take part in Good Pharmacopoeial Practice guidance development.
WHO Good Pharmacopoeial Practice guidance is intended to help diverse international pharmacopeias to cooperate in the development of their own national standards. Such cooperation will make sure that harmonization does not obstruct market growth but promotes the implementation of new approaches to local practice. This step is a consequential continuation of well-established collaboration. Recently WHO recognized seven “SCEEMP” laboratories as conforming to international quality standards.
Cooperation between Russian expert organizations and international institutions is a general trend today. This March Krasnoyarsk subdivision of Federal State Budgetary Institution “Information and Methodological Center for Expert Evaluation, Recording and Analysis of Circulation of Medical Products” has been internationally recognized and included into European network of official medicines control laboratories (OMCL). Quality control harmonization will essentially happen and as the result, long-lasting and durable information exchange will be developed between Russian Rosdravnadzor laboratory and more than 70 laboratories from 40 countries worldwide.
New guidance on Good Pharmacopoeial Practice is going to be published by the end of 2017. Once new approach will be implemented, access to medicinal products with the proper quality for the public will be expanded. Consequently, it will promote a new path for pharmaceutical industry development. Furthermore, mutual recognition of tests throughout OMCL laboratories will provide proper vigilance for medicines. Such evolution is beneficial for all market participants- pharmaceutical industry, regulators and Russian society
Sources:
http://dsm.ru/docs/analytics/january_2017_pharmacy_analysis.pdf
http://www.roszdravnadzor.ru/news/6430
http://www.regmed.ru/Content/News/PressRelease_20170307_WHO-GPhP
https://www.edqm.eu/en/general-european-omcl-network-geon
