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Investigational New Drug (IND) Application Process

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

2012

2013

2014

2015

2016

2017

2018

2019

2020

2021

2022

Applied INDs (by Scale)

2022

TW Single Center

40

TW Multiple Center

17

Multi-Regional Multi-Center

285

Total

342 Case

Update:2023/03/09Source:TFDA

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

2012

2013

2014

2015

2016

2017

2018

2019

2020

2021

2022

Applied INDs (by Phase)

2022

Phase I

45

Phase II

86

Phase III

146

Phase IV/Others

65

Total

342 Case

Update:2023/03/09Source:TFDA

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

2012

2013

2014

2015

2016

2017

2018

2019

2020

2021

2022

2012

2013

2014

2015

2016

2017

2018

2019

2020

2021

2022

Multiregional clinical trial (MRCT)

2022

MRCT/Total IND application per year

83.3%

Number of IND application

342

Number of MRCT application

285

Update:2023/03/09Source:TFDA

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

Neoplasms

44%

Other

12%

Infectious and Parasitic Diseases

7%

Diseases of the Musculoskeletal System and Connective Tissue

6%

Endocrine, Nutritional and Metabolic Diseases, and Immunity Disorders

6%

Diseases of the Nervous System and Sense Organs

6%

Diseases of the Skin and Subcutaneous Tissue

4%

Diseases of the Digestive System

4%

Diseases of the Circulatory System

5%

Diseases of the Respiratory System

6%

2021-2022

Update:2023/3/9 Source:TFDA