ICMRA-ICH-IPRP-PICS Joint Work Plan for Harmonisation and Convergence
- Date
- November 19, 2024
- Category
EU Regulations
- Description
In September 2024 ICMRA-ICH-IPRP-PICS published a “Joint Work Plan for Harmonisation and Convergence Work to Advance Development of a Regulatory Pharmaceutical Quality Knowledge Management Capability”. This plan provides an overview of the harmonisation work to be undertaken by each of the four organisations that will contribute to the development of a Pharmaceutical Quality Knowledge Management System (PQKMS).
The proposed harmonisation focuses on the following areas:
- ICH proposed to undertake work primarily focused on further specification or clarification of harmonized requirements for the quality sections of the electronic common technical document (CTD) and the data elements and data standards related to those CTD module 2 and 3 submissions.
- IPRP proposed to undertake work on convergence of regulatory expectations among regulators regarding quality assessments for new applications and in relation to post-approval changes (PACs), taking into consideration available harmonized technical guidelines.
- PIC/S proposed to carry out work-focused revisions to the PIC/S inspection report template to enable a structured data format to facilitate electronic data exchange, and continued work to develop tools and templates for pharmaceutical quality system (PQS) assessment for inspectors and work on related inspector training modules.
- Assess the need for internationally harmonized unique identifiers to enable the envisioned PQKM capabilities supporting regulatory collaboration and reliance, and explore approaches to establishment and governance of a secure standardized technology platform for PQKM.
The document provides detailed tables for each of the participating organisations with key actions and estimated timelines of identified areas of harmonisation work.