All Regulation articles
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JournalControlled substances development – past, present, and future
Controlled substances present unique challenges and extra regulations compared to their non-controlled counterparts. Over time in Europe and the US, governing bodies have continually increased the burden on sponsors to demonstrate safety and efficacy. This includes legislation specific to controlled substances; dictating how they can be stored, destroyed, labeled, administered, ...
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EditorialMind the gap:
Innovation vs
regulation of ATMPsTechnology has always developed faster than regulation – but the pace at which science is advancing is not being matched by progress of the current regulatory framework which, in stark contrast, is consultative, slow, and regional.
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JournalThe importance of subjective and qualitative risk management for medical devices regulation
In the early 2000s, risk management was thought to be able to offer the medical devices industry an exponential game-changing quality revolution. The developments brought by the Japanese quality philosophy, or total quality management, had seen many industries − such as aerospace and automobile production – make a paradigm shift ...