Generic Drug Development in USA, Europe and Mexico with Harmonization: A Regulatory Insight

Abstract

The availability of generic medication is an important issue in the regions like USA, Europe and Mexico. Cost explosion in the health care systems heat up the political argumentation on generic products and centre the discussion also within the public. This master thesis deals with the registration process of generic medicinal products in the USA, Europe and Mexico. Due to the limited scope, the thesis focuses on chemical active ingredients, administered as solid oral dosage forms. This product range is supposed to represent the most common and well-known segment of the pharmaceutical market. The time frame under examination is from submission until approval of the generic product,including a pre-submission period where the regulatory strategy is to be established. The structure of a generic documentation in all regions is illustrated, the different content of certain parts of the documentation is analysed in more detail. A comparison of all regions is made at the end of each section. The different structure of the regions, the published guidance provided by the authorities and the nature of the approval process with the involved authorities is the basis for the differences when comparing the submission and review process of generic applications. In USA and EU regions, the documentation can be filed in the CTD / eCTD format while in Mexico the format for documentation is different and it is known as Application Dossier. The eCTD is mandatory in the EU and the USA. But even when the format is the same, the content of many sections is different.