Regulator Spotlight
At the October 2024 ISPE Annual Meeting in Orlando, Florida, FDA CDER Strategic Initiatives Associate Center Director Theresa Mullin explored how regulator and company agility in managing pharmaceutical quality is pivotal in addressing the problems of drug shortages and availability and how international regulatory collaboration and harmonization is key in supporting that agility. She addressed: ● the need for a reliable supply of medicines ● causes of drug shortages ● post-approval changes (PACs) as part of effective pharmaceutical quality management ● the vision of the International Coalition of Medicines Regulatory Authorities (ICMRA) for global pharmaceutical quality knowledge management (PQKM) capability ● the ICMRA collaborative assessment and inspection pilot studies, and ● further efforts in the PQKM project.
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ABOUT THE WEEKLY SUPPLEMENT
Along with a feature story on a presentation or panel discussion at a recent 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.