EMA Regulation amendments call for framework for in silico


Amendments calling for the creation of a framework for in silico medicine have been tabled by MEP Martin Häusling (Greens/EFA, Germany) to the EMA Regulation Report by Claudiu Ciprian Tănăsescu (S&D, Romania). This report, currently being discussed by the European Parliament’s Environment, Public Health and Food Safety Committee (ENVI) Committee would amend the 2004 EU Regulation on the placing on the market of medicinal products and the establishment of a European Medicines Agency. 

While the reopening of this legislation is primarily to separate veterinary medicines from medicinal products for human use, the Avicenna Alliance has been meeting with MEPs to put forward the need for this legislation to take into the potential of new technological advances which were unavailable at the time of the original legislation.

Amendment 25 in particular states “The Agency shall develop a framework for the validation of in silico models and take into consideration the opportunities presented by in silico concepts developed in toxicology aiming for predictive medicine. These can be based on human-relevant computer or cellular models, pathways of toxicity, or adverse outcome pathways.”

The Avicenna Alliance will be promote this amendment as a positive step to ensuring the legislation governing the placing on the market of medicinal products is fit for purpose and that the potential in silico medicine can offer is capitalised on for the benefit of patients and researchers.  

The full text of these Amendments can be found here:

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