ICMRA: Extension of PQKM Collaborative Pilots
The International Coalition of Medicines Regulatory Authorities (ICMRA) Pharmaceutical Quality Knowledge Management (PQKM) collaborative pilots have been extended until the end of 2025. ICMRA is actively seeking new applications for collaborative review by multiple global regulators.
There are two different pilots:
Collaborative Assessment Pilot: Aims to facilitate coordinated review of post-approval CMC changes by multiple global regulators within an agreed timetable. Proposals should focus on high-impact changes which will have a positive impact on medicine supply, including for generic drugs and biosimilars.
Collaborative Hybrid Inspection Pilot: Continues to focus on sites requiring an inspection to support submissions of manufacturing changes but will also consider sites where at least two participating authorities have a common interest for a pre-approval inspection.
The Collaborative Assessment Pilot Summary Report was published in January 2025.
The Collaborative Hybrid Inspection Pilot Summary Report was published in March 2025.
Source:
ICMRA: Extension of the ICMRA PQKM Collaborative Pilots
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