Regulator Spotlight
At the 2025 DIA/RAPS Summit on Combination Products in the EU, held in Brussels at the end of January, EMA Procedures Office Head Virginia Rojo gave an update on the agency’s ongoing efforts to support companies in dealing with lifecycle management of combination products (CPs). She discussed the relationship between the current CP guidance and the draft variation classification guidance, and the increased focus on assessing the risk and impact of changes to the medicinal product.
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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.
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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.