Regulator Spotlight
A panel session at the 2025 CASSS WCBP Conference brought together international regulatory leaders to discuss “navigating the regulatory landscape: global convergence and innovation in biopharmaceutical manufacturing.” Participating in the panel discussion were Japan PMDA’s Yasuhiro Kishioka and Akihiro Ishiguro, EMA’s Anabela Marçal, Swissmedic’s Claudia Müller, Health Canada’s Sophie Sommerer, and WHO’s Rogério Gaspar.
The panelists began by explaining the roles their departments play and the structure, mission, key priorities, and recent regulatory and legislative initiatives of their respective agencies and WHO. The Q&A that followed allowed the panelists to further explore: ● inter-agency collaborations between EMA, FDA, and other agencies ● the Access Consortium and assessment of CGTs ● the role of PMDA’s new office in Washington DC ● initiatives to support innovation in manufacturing and technology ● interactions between reviewers and inspectors ● information sharing through Accumulus and other IT platforms ● learnings from and evolution of the ICMRA assessment pilots, and ● alignment on platform technology designations.
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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.