(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)
ICMRA’s CHIP Initiative Streamlines Global Medicine Inspections
The International Coalition of Medicines Regulatory Authorities (ICMRA) launched the Collaborative Hybrid Inspection Pilot (CHIP) in 2021 to address regulatory delays in medicine approvals. The initiative allowed manufacturers to submit a single CMC dossier for simultaneous hybrid inspections by multiple regulators, reducing redundancy and improving medicine availability.
Participating Agencies
Regulators included the FDA, EMA, MHRA, Swissmedic, Health Canada, ANVISA, MOH Israel, PMDA, and HPRA, acting as full members or observers.
Key Outcomes
- Three successful inspections covering different medicinal products and post-approval changes.
- Consensus on inspection findings and compliance outcomes.
- Agreement on CAPA plans and post-inspection actions.
- Proof of feasibility within existing legal frameworks, avoiding extra regulatory burdens or delays.
The pilot demonstrated the benefits of global regulatory collaboration in expediting medicine access. Full details are available in the report.
17-03-2025