Regulator Spotlight
In a late January 2025 webinar on “Modular Manufacturing and Point-of-Care Regulations,” Medicines and Healthcare Products Regulatory Agency (MHRA) leaders discussed the new regulatory framework to support decentralized manufacturing (DM) that comes into force in the UK in July 2025.
MHRA Inspectorate Strategy and Innovation Unit Manager Ian Rees covered: • MHRA responsibilities, mission and vision • an overview of the new DM framework • manufacturing technology models • the new legislation, and • international and institutional perspectives. Expert Pharmaceutical Assessor Elspeth Gray followed with a discussion of: • the qualifying tests that define eligibility for decentralized manufacturing, and • the DM master file. Rees returned to discuss future steps, including guidances, workshops, and international collaborations.
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