Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products
Salmikangas, P.; Flory, E.; Reinhardt, J.; Hinz, T.; Maciulaitis, R. · Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz · 2009 · Heft 11 · S. 24 bis 29
Bibliografische Angaben
Zusammenfassung
The new era of regenerative medicine has led to rapid development of new innovative therapies especially for diseases and tissue/organ defects for which traditional therapies and medicinal products have not provided satisfactory outcome. Although the clinical use and developments of cell-based medicinal products (CBMPs) could be witnessed already for a decade, robust scientific and regulatory provisions for these products have only recently been enacted. The new Regulation for Advanced Therapies (EC) 1394/2007 together with the revised Annex I, Part IV of Directive 2001/83/EC provides the new legal framework for…
