Real-Time Release Testing Promised Faster Drug Batch Release, Yet Industry Adoption Stays Slow
A new review finds that despite decades of harmonized global regulatory support, real-time release testing remains limited to mostly hybrid ...
Tag: EMA
Herbal medicines face a hard road from tradition to clinical proof
A narrative review maps why complex herbal formulations struggle to meet modern clinical and regulatory standards worldwide.
Europe’s fragmented medical device rules fuel calls for a central EU agency
A new analysis argues that Europe's decentralised medical device regulatory system suffers from fragmentation, inconsistent evidence standards and declining innovation, ...
FDA, EMA and NMPA differ in how they assess radiopharmaceuticals, review finds
A review published in EJNMMI Radiopharmacy and Chemistry compares how the FDA, EMA and NMPA evaluate radiopharmaceuticals before clinical use ...
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