ICMRA publishes Hybrid Inspection Pilot Summary Report

Ensuring a global supply of medicines is a complex process requiring approvals from multiple regulatory authorities, each with different requirements and timelines. These differences can delay patient access to essential medicines. To address this challenge, the International Coalition of Medicines Regulatory Authorities (ICMRA) launched the "Collaborative Hybrid Inspection Pilot (CHIP)" in 2021. The initiative allowed manufacturers to submit a single Chemistry, Manufacturing, and Controls (CMC) dossier, which could undergo simultaneous hybrid inspections by multiple regulatory authorities. The key goals were to enhance regulatory collaboration, reduce redundant assessments, and improve medicine availability.  The pilot highlighted the benefits of knowledge sharing and global cooperation in accelerating medicine access. This report now outlines key findings and proposes next steps to further strengthen regulatory collaboration.

Regulatory agencies including the US FDA, EMA, MHRA, Swissmedic, Health Canada, ANVISA, MOH Israel, PMDA, and HPRA participated as either full members or observers. 

Key Outcomes

• Three successful inspections covering different medicinal products and post-approval changes. 
• Consensus among regulators on inspection findings and compliance outcomes. 
• Agreement on corrective and preventive action (CAPA) plans and post-inspection requests. 
• Demonstration that collaboration is feasible within existing legal frameworks, without adding regulatory burdens or delays. 

Details can be found in the report.