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

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

https://www.gmp-compliance.org/files/guidemgr/guideline-quality-non-clinical-and-clinical-aspects-medicinal-products-containing-genetically-modified-cells-revision-1_en.pdf

Origin/Publisher:

EMA, 1083 HS Amsterdam ? The Netherlands

Document Type:
Guideline
Content:
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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