Masterstudiengang "Drug Regulatory Affairs"


Regulatory Strategy for the Development of Known Drugs in New Therapeutic Areas ***

Dr. Janni Papakrivos (Abschlußjahr: 2011)


In the face of higher development risks due to tight regulatory and cost benefit scrutiny, drug companies are under growing pressure to increase R&D productivity and to decrease investment costs. One effective way of tackling these challenges is to develop qualified drugs in new therapeutic areas while relying on investigations already conducted for these drugs. This approach, commonly known as repurposing, has the potential to be truly innovative, cost-effective and lower risk. With the advent of new tools facilitating drug developers to screen approved compounds for new treatments, the repurposing of known drugs should become a steady pillar in every R&D department. In this work, current U.S. and EU regulations are reviewed, compared and assessed for their effectiveness. A regulatory strategy highlighting the importance of Freedom To Operate and early Health Technology Assessment is proposed. When compared to the U.S., EU regulations are less supportive, more restrictive and under certain circumstances even futile. As the development of known drugs in new therapeutic areas can provide much benefit to industry, public health and healthcare payers, European legislators should increase their efforts to facilitate such developments.

Pages: 44, Annexes: A-D, 54

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