The world covers more than 190 countries in which at the moment in most of them pharmaceutical legislations and regulatory requirements are established and implemented, e.g. to describe the marketing authorization procedure for medicinal products. To be able to submit a marketing authorization application in all these countries, it is important to know exactly the pharmaceutical legislations (regulations, directives and guidelines) and the regulatory requirements in each of the country in advance. The aim of the dissertation lies in the development of a global regulatory strategy for the...