Comparison of Regulatory Requirements for Pharmaceuticals in Non- European Union Member States Kosovo, Ukraine and Serbia

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Author(s): Shivani Jani*, Nilesh Patel, Urvi Chotaliya, Ashok Patel.

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs

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Background:- Literature review suggested that regulatory guidelines should be harmonized in the world for better processing of applications and for the upliftment of the regulatory field. So there was a thought to compare the guidelines for countries where there is more requirement of harmonization. And so Kosovo, Ukraine and Serbia were selected because they are countries of Europe but they are not the part of EU.

Introduction:- Kosovo, Ukraine and Serbia are small countries of Europe but they are not the member of European Union. They have their own guidelines for submission of MAA for marketing of pharmaceuticals and medical devices. They are trying to get the EU membership and so the thought was worthwhile to compare the guidelines of these countries.

Method:- The registration process of pharmaceuticals in Kosovo, Ukraine and Serbia was studied throughly. Along with it the guidelines for European Union were also studied. Comparison of guidelines of all the three countries with the guidelines of European Union for pharmaceuticals was done.

Result:- The comparison of guidelines showed that there are still some changes needed in the guidelines of Kosovo, Ukraine and Serbia before they can merge with the guidelines of European Union. Some of the points in the guidelines are very different from the guidelines of EU.

Conclusion:- So it was worthwhile to study the regulatory requirements of pharmaceuticals in Non-European Union Member States Kosovo, Ukraine and Serbia.

Keywords: Active drug users, HAART, antiretroviral effectiveness, treatment adherence, multidisciplinary care, HIV-1, CD4, ADU, NRTIs, cohort, regulation, guidelines, comparison, Kosovo, Ukraine, Serbia, pharmaceuticals

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(E-pub Ahead of Print)
DOI: 10.2174/2213476X06666190624152156