Published Paper Details:

The availability of generic medication is an important issue in the regions like the USA, Europe, and Mexico. The public debate on generic products is at the forefront as a result of the cost explosion in the health care systems. The registration procedure for generic medicines in the USA, Europe, and Mexico is the subject of this master's thesis. The thesis's narrow scope forces it to concentrate on chemical active substances used in solid oral dosage forms. This product line is meant to represent the pharmaceutical market's most prevalent and well-known market sector. The time period under consideration includes the pre-submission phase during which the regulatory strategy must be formulated, as well as the period from submission to the approval of the generic product. The structure of generic documentation in all regions is illustrated, and the different content of certain parts of the documentation is analyzed in more detail. A comparison of all regions is made at the end of each section. When comparing the filing and review process of generic applications, discrepancies arise due to regional differences in structure, published guidelines from the authorities, and the nature of the approval procedure with the participating authorities. The CTD/eCTD format is available for filing documents in the USA and EU areas, however the Application Dossier format is used in Mexico. In the EU and the USA, the eCTD is required. However, many sections have diverse material even though the format is the same.