Following the endorsement of a harmonised guideline for general principles for model-informed drug development (MIDD) in November 2022, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M15 Expert Working Group has developed a draft guideline to cover the general principles and good practices for its use and this is now under public consultation.
MIDD is an approach that plays an extremely valuable role in drug development and has been reported to increase the success of clinical trials by up to 30%, which demonstrates its growing impact in regulatory affairs.
MIDD can help analyse the risks, benefits and the overall patient outcome. Using it can improve decision-making and efficiency during the development phase by providing crucial information on diagnosis, treatment and prevention.
To ensure the proper application of MIDD, the ICH has released the ‘General Principles for Model-Informed Drug Development - M15.’ This new guideline covers several areas of MIDD such as model evaluation, model risk and impact, reporting, submission, analysis planning and more. A table for assessment has also been provided.
The ICH M15 guideline can help regulatory affairs professionals to better understand risk assessments and learn how to efficiently assess data from tests. Universal frameworks, such as this ICH M15 guideline, create consistency and streamline development processes within the regulatory space.
Comments or suggestions for this draft guideline should be submitted by 28 February 2025. Comments need to be completed in a template and sent to ich@ema.europa.eu. Further information can be found on the ICH’s website.
