Regulator Spotlight
At the “regulatory considerations” session of the CASSS/AMM mRNA symposium, held in Gaithersburg, MD in late May 2025, Medicines and Healthcare Products Regulatory Agency (MHRA) Senior Pharmaceutical Assessor Ka-Wei Wan provided an overview of MHRA’s engagement with individualized mRNA cancer immunotherapies, with a focus on the CMC issues involved. After outlining developments in the mRNA field, she discussed the draft guidance that MHRA released on the regulatory considerations for individualized mRNA cancer immunotherapies. She then highlighted the comments received on the draft and some of the next steps MHRA will be taking to facilitate product development and the regulatory interface.
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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.