EMA: richtlijn over kwaliteit, niet-klinische en klinische vereisten voor geneesmiddelen voor onderzoek naar geavanceerde therapie in klinische onderzoeken
The European Medicines Agency has released for public consultation a guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials.
The guideline provides guidance on the structure and data requirements for a clinical trial application for exploratory and confirmatory trials with advanced therapy investigational medicinal products (ATIMPs).
The guideline is multidisciplinary and addresses development, manufacturing and quality control as well as non-clinical and clinical development of ATIMPs. Considerations on genome editing tools are included. Throughout the guideline, requirements for exploratory trials (including First in Human studies) and confirmatory trials are described. The main focus is however on the requirements for exploratory trials.
The draft paper is available by clicking here.
Comments should be provided using this template and sent to AdvancedTherapies@ema.europa.eu by 1 August 2019.
Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.
For more information on the European regulatory system for medicines, please click here (brochure available in all languages).