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Investigational New Drug (IND) Application Process

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

2013

2014

2015

2016

2017

2018

2019

2020

2021

2022

2023

Applied INDs (by Scale)

2023

TW Single Center

52

TW Multiple Center

25

Multi-Regional Multi-Center

295

Total

372 Case

Update:2024/01/31Source:TFDA

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

2013

2014

2015

2016

2017

2018

2019

2020

2021

2022

2023

Applied INDs (by Phase)

2023

Phase I

56

Phase II

74

Phase III

169

Phase IV/Others

73

Total

372 Case

Update:2024/01/31Source:TFDA

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

2013

2014

2015

2016

2017

2018

2019

2020

2021

2022

2023

2013

2014

2015

2016

2017

2018

2019

2020

2021

2022

2023

Multiregional clinical trial (MRCT)

2023

MRCT/Total IND application per year

79.3%

Number of IND application

372

Number of MRCT application

295

Update:2024/01/31Source:TFDA

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

Neoplasms

43%

Other

17%

Infectious and Parasitic Diseases

5%

Diseases of the Musculoskeletal System and Connective Tissue

4%

Endocrine, Nutritional and Metabolic Diseases, and Immunity Disorders

6%

Diseases of the Nervous System and Sense Organs

7%

Diseases of the Skin and Subcutaneous Tissue

5%

Diseases of the Digestive System

4%

Diseases of the Circulatory System

4%

Diseases of the Respiratory System

5%

2019-2023

Update:2024/5/23 Source:TFDA