Development of a cell-based medicinal product: Regulatory structures in the European Union

British Medical Bulletin

Volumn 105, Issue 1, 2013, Pages 85-105

  Gálvez, Patricia ^a   Clares, Beatriz ^b   Hmadcha, Abdelkrim ^a,c   Ruiz, Adolfina ^b   Soria, Bernat ^a,c  

^a CABIMER Andalusian Center for Molecular Biology and Regenerative Medicine CSIC University of Seville UPO   (Spain)

^b UNIVERSITY OF GRANADA   (Spain)

^c INSTITUTO DE SALUD CARLOS III   (Spain)

Author keywords

advanced therapies; cell therapy; regulatory agencies

Indexed keywords

COLLAGEN; PLANT MEDICINAL PRODUCT; ANTIBIOTIC AGENT; ANTIINFECTIVE AGENT; HERBACEOUS AGENT; PLACEBO;

ARTICLE; CARCINOGENICITY; CARTILAGE CELL; CELL THERAPY; CHEMICAL STRUCTURE; CLINICAL RESEARCH; DRUG EFFICACY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EUROPE; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; GENE THERAPY; GOOD MANUFACTURING PRACTICE; GRAFT VERSUS HOST REACTION; HUMAN; KERATINOCYTE; MARKETING; MEDICAL DEVICE; MEDICAL DEVICE REGULATION; MESENCHYMAL STROMA CELL; NONHUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; RISK ASSESSMENT; SOMATIC CELL THERAPY; STEM CELL; STEM CELL TRANSPLANTATION; TISSUE ENGINEERING; ADULT STEM CELL; BLOOD COMPONENT; BONE MARROW TRANSPLANTATION; CELL LYSATE; CELL PROLIFERATION; DRUG INDUSTRY; ENVIRONMENTAL MONITORING; EUROPEAN MEDICINES AGENCY; FOLLOW UP; GENE EXPRESSION; PATIENT SAFETY; PHASE 2 CLINICAL TRIAL (TOPIC); PHYSICAL CHEMISTRY; RISK MANAGEMENT;

CELL- AND TISSUE-BASED THERAPY; CHRONIC DISEASE; CONSUMER PRODUCT SAFETY; EUROPEAN UNION; HUMANS; LEGISLATION, DRUG; MEDICINE; PUBLIC HEALTH;

EID: 84876221605     PISSN: 00071420     EISSN: 14718391     Source Type: Journal    
DOI: 10.1093/bmb/lds036     Document Type: Article

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