Eudralex Volume 3 NOTE FOR GUIDANCE ON THE QUALITY, PRECLINICAL AND CLINICAL ASPECTS OF GENE TRANSFER MEDICINAL PRODUCTS
Title:
Eudralex Volume 3 NOTE FOR GUIDANCE ON THE QUALITY, PRECLINICAL AND CLINICAL ASPECTS OF GENE TRANSFER MEDICINAL PRODUCTS
Origin/Publisher:
European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/
Document Type:
Note for Guidance
Content:
The Objective of this note for guidance is to provide recommendations with respect to the quality, preclinical and clinical aspects of gene transfer medicinal products and assistance in generating data supporting marketing authorisation applications within the european community.