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Investigational New Drug (IND) Application Process

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

2011

2012

2013

2014

2015

2016

2017

2018

2019

2020

2021

Applied INDs (by Scale)

2021

TW Single Center

46

TW Multiple Center

37

Multi-Regional Multi-Center

298

Total

381 Case

Update:2022/02/15Source:TFDA

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

2011

2012

2013

2014

2015

2016

2017

2018

2019

2020

2021

Applied INDs (by Phase)

2021

Phase I

53

Phase II

106

Phase III

150

Phase IV/Others

72

Total

381 Case

Update:2022/02/15Source:TFDA

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

2011

2012

2013

2014

2015

2016

2017

2018

2019

2020

2021

2011

2012

2013

2014

2015

2016

2017

2018

2019

2020

2021

Multiregional clinical trial (MRCT)

2021

MRCT/Total IND application per year

78%

Number of IND application

381

Number of MRCT application

298

Update:2022/02/15Source:TFDA

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

Neoplasms

36%

Other

25%

Infectious and Parasitic Diseases

5%

Diseases of the Musculoskeletal System and Connective Tissue

4%

Endocrine, Nutritional and Metabolic Diseases, and Immunity Disorders

5%

Diseases of the Nervous System and Sense Organs

7%

Diseases of the Skin and Subcutaneous Tissue

5%

Diseases of the Digestive System

3%

Diseases of the Circulatory System

3%

Diseases of the Respiratory System

7%

2016-2021

Update:2022/2/15 Source:TFDA