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Investigational New Drug (IND) Application Process

Applied INDs (by Scale)(Select chart for the year detail)

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019

2020

Applied INDs (by Scale)

2020

TW Single Center

50

TW Multiple Center

29

Multi-Regional Multi-Center

276

Total

355 Case

Update:2021/05/31Source:TFDA

Applied INDs (by Phase)(Select chart for the year detail)

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019

2020

Applied INDs (by Phase)

2020

Phase I

84

Phase II

91

Phase III

147

Phase IV/Others

33

Total

355 Case

Update:2021/05/31Source:TFDA

Investigational New Drug (IND) Application Process(Select chart for the year detail)

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019

2020

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019

2020

Multiregional clinical trial (MRCT)

2020

MRCT/Total IND application per year

78%

Number of IND application

355

Number of MRCT application

276

Update:2021/05/31Source:TFDA

The Number of IND Approval by Therapeutic Area(Select chart for the corresponding detail)

Neoplasms

40%

Other

19%

Infectious and Parasitic Diseases

8%

Diseases of the Musculoskeletal System and Connective Tissue

5%

Endocrine, Nutritional and Metabolic Diseases, and Immunity Disorders

5%

Diseases of the Nervous System and Sense Organs

6%

Diseases of the Skin and Subcutaneous Tissue

6%

Diseases of the Digestive System

4%

Diseases of the Circulatory System

4%

Diseases of the Respiratory System

3%

2016-2020

Update:2021/05/31 Source:TFDA