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• FDA aligns with MHRA and EMA on adaptive design for Phase 3 trial • After successful Scientific Advice Meeting, Company accepts MHRA request to become he Company’s’ sponsor into Project Orbis to harmonize regulatory review with FDA and EMA • CBER recently re-opened Project Orbis to foreign-sponsored U.S. companies only

As AI-enabled Software as Medical Devices become more prevalent, regulatory agencies are responding with new guidelines and AI-specific authorisation routes. This article looks at current trends, suggests clinical considerations for medical device developers and anticipates AI-enabled SaMDs’ future progress.

Nottingham, UK - Upperton has submitted its application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the approval of its new 7,000 sq. ft sterile manufacturing facility. The submission follows the successful execution of multiple aseptic process simulations (APS media-fill batches), completed in accordance with the revised EU GMP Annex 1 (2023) requirements.

The agreement establishes a framework for cooperation between the African Medicines Agency (AMA) and the U.S. Pharmacopeia to strengthen regulatory systems, enhance capacity building, and improve access to quality-assured medical products across Africa.