Masterarbeit

Drug Regulatory Affairs and Marketing Authorisation in the Post-Soviet countries. Focus: Russia, the Ukraine and Belarus

Stanislaus Awrutski (2010)

Language : English

The Structure of Drug Registration and Post-marketing surveillance in Russia, the Ukraine and Belarus, has been compared with usual standards for Marketing Authorisation and Pharmacovigilance across the EU countries.
The aim of my thesis is to show a systematic process of Marketing Authorisation in Russia, the Ukraine and Belarus, and to identify concerns which would prompt a Drug Regulatory Affairs Manager to act. Therefore, I have focused my research on analysis of potential problems, i.e. "Murphys Law" as applied for a Manager of Drug Regulatory Affairs, or the question: "How can it go wrong?" It is very important for successful Approval, because Marketing Authorisation is performed by local Drug Regulatory Affairs Managers. However, the decision to seek Approval is made at Headquarters. With the help of the traceability system "look back" for DRA Managers, the quality of collaboration can be improved. Furthermore, my research has covered the economics and politics in each Post-Soviet country to identify several potential problems in the state registration process. For Belarus, I wrote at length about the political structure of the country; for Russia, I showed exactly the structure of Marketing Authorisation; and for the Ukraine, I made comparisons with Marketing Authorisation in the EU countries. Ukraines membership of the WTO is expected to make the pharmaceutical market and Marketing Authorisation more open and available for foreign companies. The legal texts from the Regulatory Authority in the Ukraine in English have been included without any changes, in inverted commas. My opinions and scientific research are presented in italics.

With my master's thesis, I created a basis for discussion with the authorities in the countries, which I have described.

Normally, a DRA Manager, after analysing the potential problems, would come to a decision. This step I will leave my readers to perform.


Pages: 109
Annexes:6