QNR
TW EN

scroll

Go Top

Investigational New Drug (IND) Application Process

image image

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

2015

2016

2017

2018

2019

2020

2021

2022

2023

2024

2025

Applied INDs (by Scale)

2025

TW Single Center

30

TW Multiple Center

20

Multi-Regional Multi-Center

296

Total

346 Case

Update:2026/02/24Source:TFDA

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

2015

2016

2017

2018

2019

2020

2021

2022

2023

2024

2025

Applied INDs (by Phase)

2025

Phase I

43

Phase II

76

Phase III

157

Phase IV/Others

70

Total

346 Case

Update:2026/02/24Source:TFDA

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

2015

2016

2017

2018

2019

2020

2021

2022

2023

2024

2025

2015

2016

2017

2018

2019

2020

2021

2022

2023

2024

2025

Multiregional clinical trial (MRCT)

2025

MRCT/Total IND application per year

85.5%

Number of IND application

346

Number of MRCT application

296

Update:2026/02/24Source: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