Primary source: Center for Drug Evaluation (CDE), NMPA
A public consultation has been opened for ICH M15 recommendations that will influence how modeling and simulation data must be submitted to support drug safety and efficacy in China.
Adhering to the ICH M15 will ensure that pharmacovigilance and clinical safety teams align their practices with international standards, particularly in safety signal detection, dose selection, and risk assessments.
Map this update to local PV compliance processes and update SOP/work instructions, ownership, and due dates for implementation evidence.
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Proposed implementation recommendations for modeling and simulation data in China. Includes the official Chinese translation of ICH M15 and outlines the expectations for submitting MIDD data to support safety and efficacy claims.
Pharmacovigilance and clinical safety teams should review the implementation recommendations as MIDD increasingly informs safety signal detection, dose selection, and risk assessment strategies. Harmonization with ICH M15 in China will affect how safety modeling data is presented in clinical trial applications and marketing authorization dossiers.
Map this update to local PV compliance processes and update SOP/work instructions, ownership, and due dates for implementation evidence.
The China CDE has initiated a public consultation regarding the implementation plan and Chinese translation of the ICH M15 guideline for Model-Informed Drug Development (MIDD). This guidance aims to enhance the framework for utilizing modeling and simulation in drug development and safety assessments, impacting how safety modeling data is presented in clinical trials and marketing applications.
What changed: A public consultation has been opened for ICH M15 recommendations that will influence how modeling and simulation data must be submitted to support drug safety and efficacy in China.
Why it matters: Adhering to the ICH M15 will ensure that pharmacovigilance and clinical safety teams align their practices with international standards, particularly in safety signal detection, dose selection, and risk assessments.
Practical implication: Map this update to local PV compliance processes and update SOP/work instructions, ownership, and due dates for implementation evidence.
Published from the Firecrawl policy change extraction pipeline.
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