The analysis of organizational approaches in drug registration in the EU, Ukraine, Tajikistan, Turkmenistan and Uzbekistan
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The increase of the level of drug availability to the population is one of the most important tasks of the healthcare development in any country. As the international experience shows, one of the ways to increase the availability of medicines for the population is introduction of various mechanisms of drug registration. At the moment, Ukraine like other countries of the former USSR is in the process of development and introduction of modern organizational approaches to drug registration. Therefore, the aim of the study was the comparative analysis of organizational approaches implemented in drug registration in the European Union, as well as in some countries of the former USSR, namely Ukraine, Tajikistan, Turkmenistan and Uzbekistan. It has been found that there are many similar organizational approaches to drug registration in Tajikistan, Turkmenistan and Uzbekistan. However, the cost for considering the data of the Registration Dossier for drugs is significantly different in these countries. The cheapest drug registration is in Tajikistan. The presence of the differentiated approach to the registration of imported and domestic drugs in Uzbekistan allowed increasing the number of the registered products of the Uzbek production by 26.7 times within 1996–2017. Unlike the countries mentioned, since 2014 the legislative regulations are gradually introduced in Ukraine to register medicines, which meet the European requirements. At the same time, has been found that after introduction of the European standards in organization of drug registration in Ukraine a significant increase of drugs registered in the country was not observed. The results of the study can be used when developing the interstate program of the economic cooperation between the CIS countries in the field of pharmaceutical provision of the population. In future, implementation of this program should help the regional pharmaceutical markets in the reference countries to integrate into the world pharmaceutical market.
Drug registration, pharmaceutical market, European Union, Tajikistan, Turkmenistan, Uzbekistan, Ukraine.