New product development in personalised medicines: the impact of regulatory regimes
Suhonen, Anna Elisa (2010)
Suhonen, Anna Elisa
Turun ammattikorkeakoulu
2010
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Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:amk-2010113016402
https://urn.fi/URN:NBN:fi:amk-2010113016402
Tiivistelmä
Personalised Medicine has become one of the best drivers of research and new product development in the pharmaceutical industry. It aims to develop more safe and efficient therapies with the application of pharmacogenomics. The overall purpose of this study was to compare the regulatory environments of the USA and EU and how they influence new product development in personalised medicine. The objective of the study was to analyse the regulatory requirements at different stages of the drug development process. The study was positioned as exploratory research and data was gathered using desk research approach.
Three streams of literature were reviewed to gain theoretical insight in the topic: Innovation and New Product Development, and New Drug Development. It was found that there are vast differences in the processes and regulations the regulatory bodies of the USA and EU have set for pharmaceuticals and medical devices which do influence the speed in which new drugs and diagnostics devices are commercialised. The study revealed that the US market is more advantageous for commercialising new personalised medicines in comparison to the European market in terms of the speed of the commercialisation process. Another key finding was that the regulatory regimes in the two markets make Europe a more favourable market area for diagnostics companies operating in the field of personalised medicine in terms of speed of the commercialisation process and importance mandated by the regulatory body of combining therapeutics and diagnostics.
Three streams of literature were reviewed to gain theoretical insight in the topic: Innovation and New Product Development, and New Drug Development. It was found that there are vast differences in the processes and regulations the regulatory bodies of the USA and EU have set for pharmaceuticals and medical devices which do influence the speed in which new drugs and diagnostics devices are commercialised. The study revealed that the US market is more advantageous for commercialising new personalised medicines in comparison to the European market in terms of the speed of the commercialisation process. Another key finding was that the regulatory regimes in the two markets make Europe a more favourable market area for diagnostics companies operating in the field of personalised medicine in terms of speed of the commercialisation process and importance mandated by the regulatory body of combining therapeutics and diagnostics.