EU Guides On ATMP Trials, Genetically Modified Cells To Be Finalized This Year
The 2020 work plan of the European Medicines Agency’s committee on advanced therapies shows that two keenly-awaited guidelines are due to be finalized this year.
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The European Medicines Agency's draft guideline on investigational advanced therapy medicinal products makes a clear distinction between exploratory and confirmatory clinical trials as the classical approach of distinguishing between various stages of a clinical trial is not as well defined for such products.
The European Medicines Agency is updating its five-year old guideline on drugs containing genetically modified cells to factor in rapid scientific developments in relation to gene editing technologies, and the development of promising new cancer immunotherapies, such as CAR-T cells.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-seven guidance documents have been posted on the tracker since its last update.