The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

Eudralex Volume 3 Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells


EMA, 30 Churchill Place, Canary Wharf, London E14 5EU, United Kingdom

Document Type:
Draft Guideline
The objective of this guideline was to define scientific principles and provides guidance for the development and evaluation of medicinal products containing genetically modified cells. It was targeted for products intended for use in humans and presented for marketing authorisation.

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