• Rajae Saaidi
  • Pavandeep Kataria
  • Radmila Juric
Conference paper


The pharmaceutical corporations are confronting big challenges when applying for Marketing Authorization (MA) licenses in extremely restricted environments, which are built around a variety of regulations, legislations and regulatory requirements. For novel pharmaceutical products, companies are required to submit thousands of pages of documents as part of the regulatory review process, which very often restricts companies’ and governments’ initiatives to speed up ‘time-to-market’ for medicines and minimize costs of the whole process. Furthermore, pharmaceutical companies are supposed to submit their Marketing Authorization Applications (MAA) according to their national specifications. Thus the formatting and organization of MA submission documents are dictated by the regulatory requirements of each country. Hence, pharmaceutical companies had to reformat and adjust the contents of MAA if they were applying for MA licenses across the world.


European Union Market Authorization Document Type Definition License Authority Existential Restriction 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


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Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  1. 1.LondonUK

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