Initiation of The GHWP AI-Assisted Evaluation Tool Project

Overview

The Global Harmonization Working Party (GHWP), through its Special Task Group on Common Evaluation Reliance Practice (STG-CERP) and with the support of the GHWP Technical Committee (TC), is pleased to announce the launch of the GHWP AI-Assisted Evaluation Tool Project in strategic collaboration with the GHWP (China) Academy.

Project Objective

This initiative aims to advance regulatory modernization by leveraging publicly available regulatory requirements, technical guidelines, and regulatory knowledge resources to support both regulatory authorities and the medical device industry through intelligent and efficient evaluation processes.

Core Application Scenarios

The AI engine is envisaged to streamline the following critical phases of the regulatory lifecycle:

• Dossier Preparation: Providing intelligent Q&A for application dossier writing.
• Preliminary Review: Automated filing review and initial screening.
• Technical Assessment: Identification of substantive defects within submissions.
• Documentation Support: Generation of supplementary content and formal evaluation reports.
• Decision Support: Serving as a reference for final evaluation decision-making.
  
   

Development Approach

The project will establish an intelligent evaluation support platform built on regulatory knowledge bases, Large Language Models (LLMs), and Retrieval-Augmented Generation (RAG) technologies.

Publicly available regulations, technical guidelines, classification rules, and representative case studies will be integrated into the platform. A multi-agent framework will further simulate regulatory review processes to enhance consistency, efficiency, and accuracy in evaluations.

Data Security and Compliance

Data security, privacy protection, and regulatory compliance will remain fundamental principles throughout the project. Appropriate measures, including data governance, access controls, anonymization practices, and continuous compliance oversight, will be implemented to ensure secure and responsible use of information.

Call for Collaboration

GHWP welcomes regulatory authorities, industry stakeholders, academic institutions, and technical experts to participate in this important initiative.

For further information or expressions of interest in collaboration, please contact the STG-CERP Secretary as follows:

Mr. Yingjie Liu (liuyj@cmde.org.cn)

Ms. Huanhuan Wei (hwei18@its.jnj.com)

Together, we can advance the future of intelligent and harmonized medical device regulation.