Current practices and reform proposals for the regulation of advanced medicinal products in Canada

Regenerative Medicine

Volumn 10, Issue 5, 2015, Pages 647-663

  Viswanathan, Sowmya ^a,b,c   Bubela, Tania ^d  

^a UNIVERSITY HEALTH NETWORK   (Canada)

^b UNIVERSITY OF TORONTO   (Canada)

^c University of Alberta ^*  (Canada)

^d UNIVERSITY OF ALBERTA   (Canada)

Author keywords

accelerated market approval; advanced medicinal products; cell therapy; clinical trial; gene therapy; Health Canada; market approval; medical device; orphan drug framework; regulation; regulatory reform

Indexed keywords

ADVANCED MEDICINAL PRODUCT; ALIPOGENE TIPARVOVEC; BIOLOGICAL PRODUCT; REMESTEMCEL L; UNCLASSIFIED DRUG;

ACCREDITATION; BONE MARROW DERIVED MESENCHYMAL STEM CELL; BONE MARROW TRANSPLANTATION; CANADA; CELL THERAPY; CELLS TISSUES AND ORGANS FOR TRANSPLANTATION REGULATION; CLASSIFICATION; CLINICAL EFFECTIVENESS; CLINICAL PRACTICE; CLINICAL TRIAL APPLIATION; COMMERCIAL PHENOMENA; CONDITIONAL MARKETING APPROVAL SYSTEM; DECISION TREE; DEVICE APPROVAL; DRUG APPROVAL; DRUG DELIVERY DEVICE; FACTUAL DATABASE; FOOD AND DRUG REGULATION; GENE DELIVERY SYSTEM; GENE THERAPY; GOOD LABORATORY PRACTICE; GOOD MANUFACTURING PRACTICE; GOVERNMENT REGULATION; HEALTH CARE POLICY; HUMAN; INDUSTRY AND INDUSTRIAL PHENOMENA; INTERNATIONAL COOPERATION; MANUFACTURING FACILITY; MARKET AUTHORIZATION; MEDICAL DEVICE REGULATION; METHODOLOGY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PRODUCT REGISTRY; PRODUCT SAFETY; REGISTRATION; REVIEW; BIOLOGICAL THERAPY; LEGISLATION AND JURISPRUDENCE; MARKETING; REGENERATIVE MEDICINE;

CANADA; CELL- AND TISSUE-BASED THERAPY; COMMERCE; DECISION TREES; DRUG APPROVAL; GENETIC THERAPY; MARKETING; REGENERATIVE MEDICINE;

EID: 84938573621     PISSN: 17460751     EISSN: 1746076X     Source Type: Journal    
DOI: 10.2217/rme.15.28     Document Type: Review

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