DGRA e.V. - STUDIENARBEITEN / MASTER-THESIS

Summary

This Master-Thesis is a guide on strategic regulatory aspects, which should be taken into account when a biologic is registered internationally. As a marketing authorization is the basis for revenues, it is recommended to determine the supply chain carefully, to develop a data package, which meets international needs, to prepare and submit less detailed CMC information than the MAA, to make sure the timing is suitable regarding the availability of a CoPP and submission and approval timelines, and to apply for reduced in country testing. The evaluation of these criteria is followed by a guidance on how to come to a well considered decision for two regulatory strategies, namely to submit less detailed CMC information and to apply for reduced in country testing, in general and for the emerging markets Russia, Brazil and Mexico in particular. Three real cases from 2008/ 2009, the registration of a monoclonal antibody in Russia, Brazil and Mexico are compared to the country specific theoretical best balanced regulatory strategy.