Regulatory frameworks for gene and cell therapies in Japan

Advances in Experimental Medicine and Biology

Volumn 871, Issue , 2015, Pages 147-162

  Maeda, Daisuke ^a   Yamaguchi, Teruhide ^a   Ishizuka, Takami ^a   Hirata, Masakazu ^a   Takekita, Kazuhiro ^a   Sato, Daisaku ^a  

^a PHARMACEUTICALS AND MEDICAL DEVICES AGENCY   (Japan)

Author keywords

Act on the safety of regenerative medicine; Cell therapy; Gene therapy; Guidelines; Japan; Pharmaceuticals and medical devices act

Indexed keywords

ANIMAL; BIOLOGICAL THERAPY; CLINICAL TRIAL (TOPIC); DRUG CONTROL; ETHICS; GENE THERAPY; HUMAN; JAPAN; LEGISLATION AND JURISPRUDENCE; MARKETING; METHODOLOGY; PATIENT SAFETY; PRACTICE GUIDELINE; PROCEDURES; QUALITY CONTROL; REGENERATIVE MEDICINE; TRANSLATIONAL RESEARCH;

ANIMALS; CELL- AND TISSUE-BASED THERAPY; CLINICAL TRIALS AS TOPIC; DRUG AND NARCOTIC CONTROL; GENETIC THERAPY; HUMANS; JAPAN; MARKETING; PATIENT SAFETY; PRACTICE GUIDELINES AS TOPIC; QUALITY CONTROL; REGENERATIVE MEDICINE; RESEARCH DESIGN; TRANSLATIONAL MEDICAL RESEARCH;

EID: 84942068657     PISSN: 00652598     EISSN: 22148019     Source Type: Book Series    
DOI: 10.1007/978-3-319-18618-4_8     Document Type: Chapter

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