The EMA/HMA network strategy to 2025 supports the uptake computer modelling and simulation


On 8 December, the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have published their final European medicines agencies network strategy to 2025 giving their strategic direction to work of the European Medicines Regulatory Network.

This joint EMA & HMA draft strategy was previously open for public consultation from July to September. The Avicenna Alliance, under the leadership of the Policy Development Working Group, provided Avicenna Members inputs that were carefully analysed and captured into the final strategy which contains the following text:

"Regulators must be able to provide scientific advice as well as apply modelling/simulation analyses on applicant data during assessment. Modelling and simulation are already pivotal in developing medicines, but it will require further capability building within the Network to utilise its potential, including enabling better inclusion of subgroup perspectives such as paediatric, pregnant women etc."

We are pleased to report that the Avicenna’s response to the public consultation was seriously been backed by the EMA and the HMA. The final strategy specifically includes the need to focus further attention to unleash the potential of computer modelling and simulation and allow for better inclusion of subgroup perspectives.

Among the objectives pursued by its EMA & HMA network strategy to 2025, we have noted that the agencies will seek to optimise capabilities in modelling, simulation and extrapolation and invest in special population initiatives. This objective will be fostered under the general goal of the Agencies to foster collaborative evidence generation, improving the scientific quality of evaluations and ensuring generation of evidence useful to all actors in the lifecycle of medicines, including HTA and pricing and reimbursement authorities.

This new mention of the benefits of computer modelling and simulation in the final European medicines agencies network strategy to 2025 provides with us with additional evidence of the medicines agencies support for the uptake of in silico medicine. The reference to paediatric populations will certainly be useful in our future work on the regulation of paediatric medicines and the implementation of the EU pharmaceutical strategy.

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