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European Commission (EC) – International Coalition of Medicines Regulatory Authorities (ICMRA) publishes collaborative hybrid inspection pilot (CHIP) summary report

Post-approval Chemistry, Manufacturing, and Controls (CMC) changes are critical to continued global availability of medicines to patients. Depending on the nature of the change, supporting data may need to be evaluated by the relevant regulatory authorities before implementation. However, each regional authority may have different data requirements, assessment approaches and approval timelines and may require separate inspections of the same manufacturing site (of the same changes) by different regulatory authorities. As a result, it may take years before a single modification to an approved medicinal product can be implemented globally, leading to logistical challenges and the necessity for manufacturers to maintain multiple product versions. To address the regulatory complexity, the ICMRA launched the CHIP in 2021. The initiative allowed manufacturers to submit a single CMC dossier which could undergo simultaneous hybrid inspections by multiple regulatory authorities. Please find the report outlining the outcome of this pilot.

News reported on the 2nd of April 2025 in Catapult’s regulatory round-up, read the entire report here.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (20 mai 2025). European Commission (EC) – International Coalition of Medicines Regulatory Authorities (ICMRA) publishes collaborative hybrid inspection pilot (CHIP) summary report. ELSIBI. Consulté le 19 janvier 2026 à l’adresse https://doi.org/10.58079/13yjv


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