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European regulator defends tough stance on approving gene and cell therapies

BMJ 2011; 343 doi: http://dx.doi.org/10.1136/bmj.d7675 (Published 25 November 2011) Cite this as: BMJ 2011;343:d7675
  1. Elizabeth Sukkar
  1. 1London

The European Medicines Agency (EMA) believes that the level of regulatory requirements needed to approve “advanced therapy medicinal products” are appropriate, although only one product has been approved since new EU rules were brought in three years ago to help speed up their development.

Advanced therapy medicinal products (ATMPs) is a term that comprises the much heralded gene and stem cell therapies, as well as tissue engineered products, that hold promise to cure a range of diseases, including Alzheimer’s disease and cancer, and have the potential to build organs from cells.

Regulators and product developers, including academics, small and medium sized enterprises and drug companies, met in London last week to discuss the problems facing these products.

The main issues cited included their complex regulatory approval pathway, a lack of funding from risk adverse investors, the lack of appropriate animal models to show their effectiveness, and their long term safety risks such as unwanted immune responses or the …

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