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EMA Regulation Vote result – major gains for in silico

EMA Regulation Vote result – major gains for in silico



EMA Regulation Vote result – major gains for in silico

On 10 March 2016 the European Parliament through an overwhelming majority, voted in favour of requiring the EMA to take into account alternative models in clinical trials. The Avicenna Alliance has been working with supportive Members of the European Parliament to modernize elements of the 2004 EMA Regulation to enable the in silico market and provide certainty for investors and researchers in the in silico community.

The following text was adopted by the European Parliament:

4b. ‘’The Agency shall develop a framework for the regulatory acceptance of alternative models and shall take into consideration the opportunities presented by these new concepts which aim at providing for more predictive medicines. These concepts may be based on human relevant computer or cellular models, pathways of toxicity, or adverse outcome pathways."

Nearly all amendments to this Regulation were voted through in one single bloc. Only two were deemed in need of separate votes – this was one of them.

It will take the pharmaceutical industry some time to come to terms with what has just happened. This was meant to be a non-controversial dossier, a simple matter of separating how we regulate veterinary medicines from human medicines. The Avicenna Alliance had other plans however and over the next few months the pharmaceutical industry will start to see just how big a change this amendment could bring and alter how they look at clinical trials.

Under this European Parliament backed-text, the EMA will now need to build a policy framework for alternatives such as modelling and simulation. The Avicenna Alliance will be there to inform how this framework can be built to drastically reduce costs to industry and make clinical trials far more predictive.

The Alliance now turns its attention to the European Council to ensure that this text is supported by the 28 EU Member States and that this significant progress is not lost.

The full result can be found here.


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