Search results with tag "Advanced therapy medicinal"
EMA’S GUIDE ON ADVANCED THERAPY MEDICINAL …
www.ema.europa.euQuestions and answers on comparability considerations for advanced therapy medicinal products (ATMP) (EMA/CAT/499821/2019); Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products (EMA/ CAT/80183/2014). Different rules apply to importing products into the EU before and after marketing authorisation.
Guideline on water for pharmaceutical use - CxMP adopted
www.ema.europa.euAdvanced Therapy Medicinal Products, applicants and manufacturers are advised to consult the EC guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products (ATMPs). Where relevant, the principles of this guideline may also be applied to investigational medicinal products.
Guideline on quality, non-clinical and clinical ...
www.ema.europa.eu75 materials that alone might be classified as med ical devices (combined advanced therapy medicinal 76 products). 77 Gene therapy medicinal products generally consist of a vector or delivery formulation/system 78 containing a genetic construct engineered to express a specific transgene (therapeutic sequence) for