Abstract
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.
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Saaidi, R., Kataria, P., Juric, R. (2011). SEMANTIC MANAGEMENT OF THE SUBMISSION PROCESS FOR MEDICINAL PRODUCTS AUTHORIZATION. In: Suh, S., Gurupur, V., Tanik, M. (eds) Biomedical Engineering. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-0116-2_7
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