Masterstudiengang "Drug Regulatory Affairs"

Global pharmaceutical companies face the situation that growth in Europe, Japan and the United States, so far the top markets for the pharmaceutical industry, is decreasing. This trend forces the industry to focus on the emerging markets in order to benefit from their potential.

The thesis focus on one group of promising countries belonging to the emerging markets: those gulf countries which are aligned under the Gulf Cooperation Council, namely Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and the United Arab Emirates. These countries cover a total area of approximately 24.300.000 km2 and a total population of around 39 million. The market for pharmaceutical products in these countries is increasing. The increase in population, in life expectancy and of noncommunicable diseases like diabetes, cardiovascular diseases or cancer due to the adoption of Western life style, the wealth of the region and increasing expenditures in the health sector may be accounted as reasons for the market growth.

The main prerequisite for entering theses markets is to obtain marketing authorization for the respective pharmaceutical products by the national competent authorities. Despite national authorization procedures in each country, there is the possibility to apply for a central registration via the Gulf Central Committee for Drug Registration.

This thesis provides an overview of the region; on the national registration procedures and the central registration procedure, followed by a comparison of both options with the aim to provide guidance when to choose which route for registration addressing the central question: "Is the central registration in the gulf countries an opportunity for global companies?"

The central drug registration so far offers an alternative to national drug registration procedures in the Gulf States. As such it extends the options for a company and is therefore a potential opportunity for global companies. Based on the evaluations made for the thesis the central drug registration is not unrestrictedly regarded as an opportunity. Each registration path has its advantages and disadvantages so that case-by-case decision depending on the product strategy is necessary.