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Investigational New Drug (IND) Application Process

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

2014

2015

2016

2017

2018

2019

2020

2021

2022

2023

2024

Applied INDs (by Scale)

2024

TW Single Center

33

TW Multiple Center

24

Multi-Regional Multi-Center

315

Total

372 Case

Update:2025/02/10Source:TFDA

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

2014

2015

2016

2017

2018

2019

2020

2021

2022

2023

2024

Applied INDs (by Phase)

2024

Phase I

53

Phase II

90

Phase III

167

Phase IV/Others

62

Total

372 Case

Update:2025/02/10Source:TFDA

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

2014

2015

2016

2017

2018

2019

2020

2021

2022

2023

2024

2014

2015

2016

2017

2018

2019

2020

2021

2022

2023

2024

Multiregional clinical trial (MRCT)

2024

MRCT/Total IND application per year

84.7%

Number of IND application

372

Number of MRCT application

315

Update:2025/02/10Source:TFDA

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

Neoplasms

47%

Other

8%

Infectious and Parasitic Diseases

7%

Diseases of the Musculoskeletal System and Connective Tissue

6%

Endocrine, Nutritional and Metabolic Diseases, and Immunity Disorders

4%

Diseases of the Nervous System and Sense Organs

7%

Diseases of the Skin and Subcutaneous Tissue

7%

Diseases of the Digestive System

4%

Diseases of the Circulatory System

5%

Diseases of the Respiratory System

5%

2024-2024

Update:2025-04-18 00:00:00 Source:TFDA