Gene therapy success: how to keep its promises and improve – a regulatory perspective

This paper gives an overview of gene therapy past, present and future from a regulatory perspective. The history of gene therapy clinical trials shows light and dark but in the end, gene therapy has been proven to provide durable benefits to patients, in many cases achievable with just a single dose. Eventually, some of the investigated gene therapy medicinal products gained market approval in the European Union and USA as well as in other countries. Gene therapy is increasingly becoming an important tool for patient treatment and represents a huge potential as future of medicine.

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