Avicenna Alliance provides feedback on the EU roadmap on the evaluation and revision of the general pharmaceutical legislation

On 27 April, the Avicenna Alliance has submitted its feedback to the inception impact assessment on the EU general pharmaceuticals legislation.

The revision of theEU’s general pharmaceuticals legislation is highly supported by Avicenna Alliance Members as it represents an ideal opportunity to update the regulatory framework to reflect the uptake of in silico technologies for medicinal products.

In a nutshell, Avicenna Alliance Members call on the European Commission to:

• Take into account the benefits offered by Computer Modelling and Simulation (CM&S) for regulators in assessing the benefit-risk of medicines when considering a new definition for unmet medical needs.
• Consider in silico technologies as a relevant source of data to refine, reduce and occasionally replace clinical trials, accepted by regulators and HTA bodies/payers, as evidence for approval and access to innovative therapies in unmet medical needs.
• Maintain the spirit of incentivisation when evaluating and revising the EU’s general pharmaceuticals legislation.
• Urge regulators and HTA bodies to accept evidence, particularly leveraging real-world evidence, as this encourages rapid and more efficient product development, as well as better post-marketing data collection informing benefit-risk.
• Equip the EU with a regulatory framework acknowledging the emergence of in silico technologies.
• Establish a clear regulatory pathway for the use and acceptability of in silico trials in the context of medicines and combination products development in the EU.
• Streamline the regulatory assets to include guidance for academia and industry to perform reliable and high-quality in silico trials.
• Develop harmonised common EU standards on “Good Simulation Practice” to ensure the robustness and quality of computer models in medicinal and combination products development.