Comparison of a Global Submission of New Biological or Chemical Entity: Strategic Decisions and Criteria for Implementation

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 marketing authorization application of a new chemical entity as well as for a new biological entity. For this strategy a detailed analysis of the pharmaceutical legislations and regulatory requirements in the different regions and countries in the world was made, especially to identify and discuss the commonness and the main differences. Based on the result of this analysis of the pharmaceutical legislation and regulatory requirements, a global regulatory strategy for new marketing authorization applications was developed and established.