Masterstudiengang "Drug Regulatory Affairs"


European View on Current Regulatory Legislation in the CIS Countries. Marketing Authorisation of Herbal Medicinal Products in Russia and the Ukraine ***

Alex Dranov (Abschlußjahr: 2013)

Language: English

Since the early 1990s, the new countries emerging from the former Soviet Union, commonly called CIS countries, have increasingly attracted the attention of major players in the pharma business worldwide, but especially that of the European pharmaceutical industry. Two distinct trends have been identified in the evolution of regulatory legislation in the CIS countries: some countries, like Ukraine, try to adopt as much as possible of the European/ICH perspective, whereas others, such as Russia, continue on their own path, partly influenced by the heritage of the Soviet era. Since Russia and Ukraine are the two largest and most attractive CIS markets, but pursue two distinct regulatory approaches, this work is focused primarily on comparing the legislation in those two countries with the EU regulatory framework.

The history and current development of regulatory legislation, new legal initiatives, and possibilities for harmonisation with the EU rules are extensively elaborated in two case studies on Russia and Ukraine. A third case study on the marketing authorisation of a herbal medicinal product in both countries was chosen for the illustrative purposes, especially taking into account that the rules for applying for marketing authorisation in Russia and Ukraine are similar, if not identical, for both herbal and chemical medicinal products.

All terms used in this thesis are in compliance with the current European regulatory terminology for human medicinal products. The scope of this work includes not only the initial marketing authorisation applications, but also basic principles of the clinical trials required for registration procedures as well as selected regulatory aspects of successful market access and post-marketing maintenance activities.

The thesis concludes with recommendations to EU-based pharmaceutical companies who wish to apply for marketing authorisation in the CIS region.

Pages: 74, Annexes: pages 16

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