The Avicenna Alliance, our new Association of 50% VPHi Membership and 50% Industry, can claim a major victory in the revised EMA Regulation with the introduction of new text supporting modelling and simulation and predictive medicine in medicinal product development.
The 2004 Regulation on the placing on the market of medicinal products and establishment of a European Medicines Agency (the EMA Regulation) sets out how all medicinal products are put on the market and their evaluation by the EMA.
The change to this Regulation started in late 2014 was meant to be a small affair. A simple matter of separating veterinary medicines from human medicines so they can be dealt with separately. Despite the intentions from the Commission however, this nonetheless represented a reopening of what is arguably the most important piece of EU policy on medicines in existence – an opportunity for the in silico community.
After almost a year of working with the offices of key Members of the European Parliament and many exchanges on alterations of text, the Environment, Public Health and Food Safety (ENVI) Committee voted through an overwhelming majority, the following text:
Recital 6a (new)
“Whereas advances in alternative testing require the creation of a regulatory framework capable of adapting to new developments in this field, including for example the recognition and evaluation of modelling and simulation technologies.”
Article 1 – point 5a (new), Article 6 paragraphs 4a and 4b (new)
“4b. The Agency shall develop a framework for regulatory acceptance of alternative models and take into consideration the opportunities presented by these new concepts aiming for more predictive medicine. These can be based on human-relevant computer or cellular models, pathways of toxicity, or adverse outcome pathways”
Keep in mind this change will be made to an EU Regulation. This is the highest authority of EU law. Unlike EU Directives, Regulations are directly applicable to the 28 Member States ie: from the moment it goes into force that text becomes the law of the entire European Union.
That the EMA will be called on to open its doors wider to modelling and simulation provides a great opportunity for furthering in silico medicine in the EU.
This text still must be voted on by the Parliament as a whole but the hard part is done.
The full text of the original 2004 Regulation can be found here.