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Research article

Time required for approval of new drugs in Canada, Australia, Sweden, the United Kingdom and the United States in 1996-1998

Nigel S.B. Rawson
CMAJ February 22, 2000 162 (4) 501-504;
Nigel S.B. Rawson
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Data supplements

  • Appendix 1: Approval times for new drugs, by TPP division



    Division/countryNo. of new drugs approved  Approval time (in calendar days)  
    MedianMeanRange

    AIDS and Viral Diseases    
    Canada 8546486185–815
    Australia12266305141–628
    Sweden12368349153–508
    United Kingdom 8264307182–490
    United States1113916542–344
    Bureau of Biologics and Radiopharmaceuticals    
    Canada19698808108–2454
    Australia17533576364–964
    Sweden16463467113–698
    United Kingdom 5567490174–679
    United States23459546147–2971
    Central Nervous System    
    Canada19428469273–744
    Australia19528553314–769
    Sweden2435731588–615
    United Kingdom1524533188–1119
    United States22515534241–1087
    Cardiovascular    
    Canada 9547574240–963
    Australia11538569378–1051
    Sweden20336348122–892
    United Kingdom 9308329107–642
    United States14384592183–3053
    Endocrine, Metabolism and Arthritis    
    Canada13539570253–1017
    Australia13555571314–1130
    Sweden14332351112–763
    United Kingdom 9313384137–1078
    United States22362402167–928
    Gastrointestinal, Hematology and Oncology    
    Canada21549582277–1048
    Australia14553570379–953
    Sweden12392346122–574
    United Kingdom 533034680–678
    United States18387506159–1619
    Infection and Immunology    
    Canada 8574754408–1937
    Australia 8611621383–840
    Sweden 9275362107–700
    United Kingdom 4139228107–525
    United States13365666182–1926

    Note: TPP = Therapeutic Products Program, Health Canada.

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CMAJ
Vol. 162, Issue 4
22 Feb 2000
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Time required for approval of new drugs in Canada, Australia, Sweden, the United Kingdom and the United States in 1996-1998
Nigel S.B. Rawson
CMAJ Feb 2000, 162 (4) 501-504;

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Time required for approval of new drugs in Canada, Australia, Sweden, the United Kingdom and the United States in 1996-1998
Nigel S.B. Rawson
CMAJ Feb 2000, 162 (4) 501-504;
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