Regulator Spotlight
At the 2024 UNICEF/UNFPA/WHO Manufacturers and Suppliers Meeting held in UN City Copenhagen in early December, members of WHO’s Local Product & Assistance (LPA) Unit provided insights into the unit’s technical assistance program. The TA program supports manufacturers in achieving compliance with international regulatory norms and standards in order to obtain WHO prequalification status for a medical product. The feature story in this Weekly Supplement focuses on the presentation at the meeting by Kim Notenboom, who was then completing a two-year assignment to the LPA Unit. She returned in January to the Dutch Medicines Evaluation Board, where she serves as a senior quality assessor and drug shortages expert. Included in her talk were case studies illustrating how WHO assists in meeting CMC and GMP expectations.
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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.