Eudralex Volume 3 Human cell-based medicinal products
Title:
Eudralex Volume 3 Human cell-based medicinal products
Origin/Publisher:
European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/
Document Type:
Guideline
Content:
This multidisciplinary guideline will address development, manufacturing and quality control as well as non-clinical and clinical development of cell-based medicinal products (CBMP) including somatic cell therapy medicinal products as defined in Directive 2001/83/EC, Part IV, Annex I1 and tissue engineered products as defined in Regulation 1394/2007/EC2.