On 5 June 2026, the European Medicines Agency (EMA) published a report from the HMA/EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment. The document summarises discussions among regulators, industry, academia, and patients on how to standardise the use of mechanistic models—such as physiologically based pharmacokinetic (PBPK) models and quantitative systems pharmacology (QSP) models—in drug development and regulatory decision-making. The workshop aimed to address the lack of harmonised reporting standards and qualification pathways, which currently hinder the acceptance of these models by regulatory authorities.
The report, produced by EMA in collaboration with the Heads of Medicines Agencies (HMA), outlines key recommendations for improving transparency, reproducibility, and regulatory confidence in mechanistic models. Participants agreed on the need for a common reporting template that would specify model assumptions, parameter sources, and validation steps. The workshop also discussed a potential qualification framework, similar to existing procedures for biomarkers and novel methodologies, to formally endorse models for specific regulatory uses.
Stakeholder impacts For pharmaceutical companies, clearer reporting standards could reduce uncertainty in regulatory submissions and potentially accelerate approval timelines for drugs that rely on mechanistic modelling. However, the proposed qualification framework may impose additional upfront costs for model development and documentation. Regulators, including EMA and national competent authorities, would benefit from more consistent and reliable model-based evidence, but would need to invest in training and infrastructure to evaluate increasingly complex submissions. Academic researchers and contract research organisations may face new reporting burdens but could gain wider acceptance of their models in regulatory contexts. Patient groups stand to benefit indirectly if improved modelling leads to more efficient drug development and earlier access to innovative therapies.
Next steps EMA indicated that the workshop findings will inform the development of a formal guideline on reporting and qualification of mechanistic models, expected to be drafted by the end of 2026. A public consultation on the draft guideline is anticipated in early 2027. The agency also committed to organising follow-up workshops to address specific technical challenges, such as model validation against clinical data and handling of uncertainty.
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