Module 1 2021

25/06/2021

Impact of IND Timelines on Global Studies (chemical drugs)

Months

1

2

3

4

5

6

7

8

9

10 11

12

13 14

China Korea Singapore

HGRAC included

Pre-IND included

IND preparation and translation phase

Study Start

IND submission and review phase with IND/CDE

IRB Submission and Approval

Note: in China, some site IRB/EC can accept EC submission and approval in parallel with IND, but not all sites. So need to have site selection and identify a leading site for EC submission.

25

The Organisation for Professionals in Regulatory Affairs

25

Balanced Country Selection

• Ensure future data integrity by combining countries without major ethnic differences and defining needs for recruitment caps

• Consider separate studies for countries with contradicting guidelines or agency advice

• Measure impact on global development when include countries with long study start up

• Account for requirements to supply study medication and/or concomitant therapy after completion of the study

The Organisation for Professionals in Regulatory Affairs

26

13