European regulatory tools for advanced therapy medicinal products

Transfusion Medicine and Hemotherapy

Volumn 40, Issue 6, 2013, Pages 409-412

  Flory, Egbert ^a   Reinhardt, Jens ^a  

^a PAUL EHRLICH INSTITUT   (Germany)

Author keywords

ATMP; European community; Medicinal product regulatory issues

Indexed keywords

ADVANCED THERAPY MEDICINAL PRODUCT; BIOLOGICAL PRODUCT; UNCLASSIFIED DRUG;

DRUG INDUSTRY; EUROPEAN UNION; GENE THERAPY; GERMANY; GOVERNMENT REGULATION; MARKETING; MEDICAL RESEARCH; MOLECULAR THERAPY; PRODUCT DEVELOPMENT; PRODUCT SAFETY; REVIEW; SOMATIC CELL THERAPY; TISSUE ENGINEERING; TRANSFUSION; TRANSPLANTATION;

EID: 84896522295     PISSN: 16603796     EISSN: 16603818     Source Type: Journal    
DOI: 10.1159/000356364     Document Type: Review

References (8)

1. Committee for Advanced Therapies (CAT); CAT Scientific Secretariat, Schneider CK, Salmikangas P, Jilma B, Flamion B, Todorova LR, Paphitou A, Haunerova I, Maimets T, Trouvin JH, Flory E, Tsiftsoglou A, Sarkadi B, Gudmundsson K, O'Donovan M, Migliaccio G, Ancans J, Maciulaitis R, Robert JL, Samuel A, Ovelgönne JH, Hystad M, Fal AM, Lima BS, Moraru AS, Turcáni P, Zorec R, Ruiz S, Akerblom L, Narayanan G, Kent A, Bignami F, Dickson JG, Niederwieser D, Figuerola-Santos MA, Reischl IG, Beuneu C, Georgiev R, Vassiliou M, Pychova A, Clausen M, Methuen T, Lucas S, Schüssler-Lenz M, Kokkas V, Buzás Z, MacAleenan N, Galli MC, Line A, Gulbinovic J, Berchem G, Fraczek M, Menezes-Ferreira M, Vilceanu N, Hrubisko M, Marinko P, Timon M, Cheng W, Crosbie GA, Meade N, di Paola ML, VandenDriessche T, Ljungman P, D'Apote L, Oliver-Diaz O, Büttel I, Celis P: Challenges with advanced therapy medicinal products and how to meet them. Nat Rev Drug Discov 2010;9:195-201.
2. Salmikangas P, Flory E, Reinhardt J, Hinz T, Maciulaitis R: Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products (in German). Bundesgesundheitsbl Gesundheitsforsch Gesundheitsschutz 2010;53:24-29.
3. Reinhardt J, Flory E, Büttel I, Schröder C, Fricke S, Vucinic V, Cross M, Niederwieser D: MSCs: clinical applications and European regulatory aspects;in Hematti P, Keating A (eds): Mesenchymal Stromal Cells. Biology and Clinical Applications. New York, Springer, 2013, pp 355-364.
4. Regulation (EC) 1394/2007 on advanced therapy medicinal products and amending Directive 2001/ 83/EC and Regulation No 726/2004.
5. Sanzenbacher R, Dwenger A, Schuessler-Lenz M, Cichutek K, Flory E: European regulation tackles tissue-engineering. Nat Biotechnol 2007;25:1089-1091.
6. EMA: Reflection Paper on Classification of Advanced Therapy Medicinal Products. www.ema.europa. eu/docs/en-GB/document-library/Scientific- guideline/2012/12/WC500136422.pdf.
7. Berger A, Schule S, Flory E: The certification of advanced therapy medicinal products. A quality label for product development in small and medium-sized enterprises (in German). Bundesgesundheitsbl Gesundheitsforsch Gesundheitsschutz 2011;54:816-821.
8. Directive 2004/23/EC of the European Parliament and of the Council (31 March 2004) on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. http://eur-lex.europa.eu/LexUriServ/LexUriServ. do?uri = OJ:L:2004:102:0048:0058:EN:PDF.