Global Medtech Guidance Tracker: August 2023
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-three documents have been posted on the tracker since its last update.
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Revisions to the updated EU guideline on transitioning multinational trials to the Clinical Trials Regulation are said to be “solution oriented.”
The European Medicines Agency is consulting on major changes to its decade-old guidance on the development of medicinal products for acute and long-term treatment of major depressive disorder.
The UK medicines regulator says the loss of experienced staff and the need to recruit and train new assessors resulted in temporary delays to clinical trial applications, but the crisis measures it put in place to address the situation mean it has now turned the corner.