Procedure: Investigational IND Application
Country: Global Procedure
Version #: 12/07/2023
Author: Daria Kostiuchenko
Editor: Daria Kostiuchenko

ID: GP-PhR-IND-SR
Category: Pharmaceuticals
Validity: Until MA obtaining or NRA update
Certified by: Vlad Reznikov 
Copyright: Pattern of USA Inc.                                                              

SUMMARY

The first step of any drug’s review process starts with filing and involves submitting an Investigational New Drug (IND) application. This application is sent to the NRA to request permission to ship the product to investigators within the state. To obtain this permission, the company must furnish all the required information via the IND. 
There are three IND types: An Investigator IND (a physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population), Emergency Use IND (allows the NRA to authorize the use of an experimental drug in an emergency that does not allow time for submission of an IND, e.g. under  US 21CFR, Sec. 312.23 or Sec. 312.20.  It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist), and finally the Treatment IND (for experimental drugs showing promise in clinical testing for serious or immediate life-threatening conditions while the final clinical work is conducted and the FDA review takes place).
There are two categories of INDs: Commercial (for companies planning to obtain marketing approval for a new drug) and Non-commercial (for companies filing IND for research purposes only). 

1678

Must-Have Requirements, Recognized Standards, and Certifications:

  • Manufacturing information as eCTD (cont.)
  • Chemistry, Manufacturing, and Control (CMC)
  • Investigator’s Brochure incl. animal study and toxicity
  • Pharmacology and Toxicology pre-clinical data
  • Clinical Trials Certification of Compliance Form 3674
  • Clinical Protocols (study plans) 21 CFR 312.23(a)(6)
  • Data from any prior human research and IND Applic’s
  • Information about the investigator, CVs
  • IRB approval letter
  • Drug samples

Nice-to-have:

  • cGCP 
  • cISO 9001                                         
  • cISO 14001
  • cISO 2700

Typical Gaps and Deficiencies: Insufficient data, incomplete documentation, non-compliance with regulatory guidelines

Implementation Period: Immediate

Deliverables: IND Approval by NRA/Clinical Trials Initiation                                                                     

PHASE

TASK

TASK

START

DURATION

  

Fee

  

KPI

NUMBER

TITLE

OWNER

W/M/Q/Y

in weeks

3rd Party 

Service 

State

  

0

In-house Pre-Submission Activity

              

  0.1

NDA signing or validation

Executor

week 1

1

        

  0.2

Contract Closing

MAH

week 1

1

        

  0.3

POA issuance and shipping

MAH

week 1

1

        

  0.4

Invoice is sent to MAH and paid

Executor

week 1

1

        

  0.5

Legal Document processing

Executor

week 2

1

        

  0.6

Legal Document Translations, Notary, and Apostilles 

3rd party

week 2

2

        

  0.7

SOW is approved by MAH

Executor

week 4

1

      

SOW

I

Assessment, Consultations and Planning

              

  I.1

Sending of the available-documents bundle to Executor

MAH

week 5

2

        

  I.2

Assessment of the information obtained 

Executor

week 7

2

        

  I.3

Exempt from IND Requirements Compliance Evaluation

Executor

week 7

2

        

  I.4

Pre-Consultation Briefing with MAH 

Executor

week 8

1

        

  I.5

Request for Pre-IND Consultation with NRA

Executor

week 8

4

        

  I.6

Pre-IND Consultation with NRA

Executor

week 12

1

        

  I.7

Post-Consultation Briefing with MAH

Executor

week 13

1

        

  I.8

Updating of the required-documents bundle

MAH

week 14

4

        

  I.9

Sending of the required-documents bundle to Executor

Executor

week 18

1

        

  I.10

Filling out the IND Application form

Executor

week 19

2

        

  I.11

Approval of the IND Application form

MAH

week 21

1

      

Application

  I.12

Submission of the IND Application 

Executor

week 22

1

      

Submission

II

NRA Review

              

  II.1

Safety Review

NRA

week 23

4

        

  II.2

Approval or Clinical Hold

NRA

week 27

1

      

Approval or Q&A

III

Approval or Q&A

              

  III.1

Analysis and addressing Qs to MAH

Executor

week 27

1

        

  III.2

Answering with relevant documents

MAH

week 28

1

        

  III.3

Official Response Evaluation

NRA

week 29

4

        

  III.4

Approval or Status Adjustment

NRA

week 33

1

      

Approval or Status

F

Final Phase In-house Post-Authorization Activity

              

  F.1

Service Acceptance Certificate signing

MAH

Mnth 8

1

        

  F.2

Final Invoice

Executor

Mnth 8

1

        

  F.3

Final Payment

MAH

Mnth 8

1

        

  F.4

Contract Termination

Executor

Mnth 8

1

        

  F.5

Archiving and limiting access

Executor

Mnth 9

1

      

Archiving

 

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