Current challenges in the development of novel cell-based medicinal products

Regulatory Rapporteur

Volumn 8, Issue 7-8, 2011, Pages 4-7

  Salmikangas, Paula ^a   Celis, Patrick ^b  

^a Finnish Medicines Agency   (Finland)

^b EUROPEAN MEDICINES AGENCY   (United Kingdom)

Author keywords

Advanced therapy medicinal product (ATMP); Cell based medicinal product (CBMP); Committee for advanced therapies (CAT); Current good manufacturing practice (cGMP); EMA working parties; Marketing authorisation; Somatic cell therapy; Tissue engineering

Indexed keywords

ARTICLE; ATMOSPHERE; IMMUNOTOXICITY; KNOWLEDGE; LEGAL ASPECT; MEDICINE; MUTAGENESIS;

EID: 80052827726     PISSN: 17428955     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (24)

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2. Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products. Official Journal of the European Union, L 242/3 of 15 September 2009
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