PV Bulletin

Public Consultation on ICH M15 Implementation in China

China's CDE opens public consultation for the ICH M15 guideline on Model-Informed Drug Development (MIDD), impacting safety assessments.

Primary source: Center for Drug Evaluation (CDE), NMPA

PV Impact Brief

Urgency: HighConfidence: high

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.

Action needed

Map this update to local PV compliance processes and update SOP/work instructions, ownership, and due dates for implementation evidence.

Relevant for
Regulatory Intelligence LeadSignal Management LeadQPPV
Processes impacted
Signal Management
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Policy change details

Document type
Consultation / Draft Guidance
Policy status
consultation
Publication date
2026-07-31
Policy change
The China CDE has opened a public consultation on the implementation plan and Chinese translation of the ICH M15 guideline for Model-Informed Drug Development (MIDD). The guidance provides a framework for using modeling and simulation to support drug development decisions and safety assessments.

Key changes

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.

Affected workflows

Signal Management

Responsible groups

Clinical SafetyPharmacometricsRegulatory Affairs

PV impact

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.

View regulator source

Source document details

Extracted documents

Evidence and confidence

Confidence: highSource updated: Jul 31, 2026

Full briefing

Practical implication

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.

View original source

Published from the Firecrawl policy change extraction pipeline.

#Safety Signals#policy-change#consultation#Guidance#firecrawl-policy-agent#Consultation / Draft Guidance#Center for Drug Evaluation (CDE), NMPA

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