Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulation of the pharmaceutical market in the EAEU, Russia and Ukraine: Similarities and differences

Andre Zernov (Abschlußjahr: 2017)

Summary
Language: English
The different economic and political situation in the former USSR Republics has led to the formation of different health systems tailored precisely to the needs of the respective country. The uneven development of health systems results also in significant differences with respect to the regulation of the pharmaceutical market. In general, the legal hurdles regarding the marketing of medicinal products have been increased steadily during the previous 20 years (focusing on ICH Guidelines as harmonization tool in the EU or USA) and the way to a successful marketing authorization has become a serious challenge.
Russia and Ukraine as well as the EAEU represent very attractive markets with high growth potential. Such factors as big market size, deficits in the research and development of local innovative medicines, large patient populations (in Russia approx. 140 million, in Ukraine approx. 40 million and in the entire EAEU approx. 180 million), poor access to essential drugs and resulting high level of dependence on the imported drugs favour the further expansion of foreign pharmaceutical manufacturers.
The task of this master thesis was to investigate several regulatory aspects that are essential for a successful marketing approval and should be clarified by pharmaceutical manufacturers prior to the application submission. Accordingly, the present work deals with the issue identifying the most important differences between the EU GMP and Russian GMP requirements in order to give a better overview of local GMP peculiarities determined in Russia. In addition, the GMP requirements defined in the EAEU and Ukraine have been discussed and most significant points were highlighted. Another important aspect that has been analysed within the framework of this thesis is the harmonization of pharmacopoeial standards and the acceptance of the European Pharmacopoeia in Russia, EAEU and Ukraine. For a good strategic planning of upcoming regulatory activities, it is crucial to know for pharmaceutical manufacturers which marketing authorization possibilities exist for their products in the target markets. Therefore, dossier requirements for certain classes of medicinal products as well as specific marketing authorization procedures established in Russia, EAEU and Ukraine were explaned in detail in the present work.
All this should allow the applicants to obtain a comprehensive overview of the specific regulatory requirements in Russia, EAEU and Ukraine and support them effectively in the strategic decisions.
Pages: 114, Annexes: pages: 69