Regulator Spotlight
The International Coalition of Medicines Regulatory Authorities (ICMRA) has extended its two regulatory collaborative pilot programs – the Collaborative Assessment Pilot (CAP) and the Collaborative Hybrid Inspection Pilot (CHIP) – and will continue to accept applications until the end of 2025. At the DIA Europe Conference session on “global partnerships to accelerate availability of quality medicines” held in Basel in March 2025, EMA leaders discussed the latest ICRMA Pilot updates, key learnings, and future directions. EMA Quality Specialist Evangelos Kotzagiorgis focused on the CAP initiative and EMA Lead Scientific Officer Brendan Cuddy reviewed CHIP.
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ABOUT THE WEEKLY SUPPLEMENT
Along with a feature story on a presentation or panel discussion at a conference in which leading regulators address the challenges and developments in a key area of concern, our Weekly Supplements include a summary listing of the “Updates in Brief,” drug GMP warning letters and recalls, and EMA non-compliance reports that have been posted on IPQ’s website during the week. Subscribers can then click through to the full posting.
Also provided, where applicable, are links to the parts of in-depth stories and Monthly Updates that have been released during the week.
Appended to the issue is a chronological listing of the headlines of the featured regulator stories since IPQ began its Weekly Supplement series in February 2024. Also appended are the headlines of the in-depth stories that IPQ has released since 2020. Those of especially high relevance to the regulator insights provided in this issue are indicated with a red star. Click on the headlines to access the stories.