Procedure: Generic Drug (ANDA) New MA
Country: Global Procedure
Version #: 01/04/2024
Author: Daria Kostiuchenko
Editor: Daria Kostiuchenko

ID: GP-PhR-AND-SR
Category: Pharmaceuticals
Validity: Reg. 5 Years
Certified by: Vlad Reznikov
Copyright: Pattern of USA Inc.

SUMMARY

Generic products undergo rigorous bioequivalence studies to establish their similarity to the reference listed drug (RLD), affirming pharmaceutical and therapeutic equivalence. The generic drug must exhibit identical characteristics in terms of active ingredients, dosage form, strength, and route of administration. The National Regulatory Authority (NRA) meticulously assesses the Marketing Authorization (MA) application, ensuring strict adherence to quality, safety, and efficacy standards. Following the evaluation, the NRA may either grant conditional approval or refuse authorization. Upon a successful review, the NRA issues formal approval, permitting the generic drug to enter the market.                                                             

Gp Pharmaceuticals Generic Drug (anda) New Ma Simplified Regulations Card Gantt Chart Page 0001

Must-Have Requirements, Recognized Standards, and Certification:                                                                  

  • GMP
  • Bioequivalence studies
  • Scientific equivalence evidence
  • eCTD
  • Structured product labeling (SPL)
  • Study tagging file (STF)                                                               

Nice-to-have:

  • ISO 9001
  • ISO 17025
  • Labeling and packaging compliance
  • Intellect. Prop. Rights Evaluation see GP-PhR-IP-SR card                   
  • Regulatory Intelligence and Strategic Consulting see GP-PhR-RI-SR card
  • Regulatory Compliance and Gap Analysis see GP-PhR-GAP-SR card
  • Authorized Representative see GP-PhR-AR-SR card                          

Typical Gaps and Deficiencies: Inconsistent regulatory requirements: Different countries may have varying requirements for generic drug registration, leading to a lack of harmonization and potential delays in the approval process. Limited access to reference products: Generic drug manufacturers may face challenges in accessing the reference products needed for conducting bioequivalence studies, which are essential for demonstrating the therapeutic equivalence of the generic drug                                                                

Implementation Period: Immediately                                                             

Deliverables: Generic Drug New MA                                                             

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

Submission

       

  I.1

Providing documents and registration file

MAH

week 5

1

    

  I.2

Ensure alignment with local regulatory guidelines

Executor

week 6

2

    

  I.3

Translations and document processing

3rd party

week 8

2

    

  I.4

Filling out the application form

Executor

week 10

1

    

  I.5

Approval of the application form

MAH

week 10

1

    

  I.6

Submission of the MA Application and Reg. File

Executor

week 11

1

   

Application

  I.7

    NRA payment

MAH

week 11

1

   

Confirmation

II

NRA Evaluation

       

  II.1

Application review

NRA

week 12

2

    

  II.2

Registration file review

NRA

week 13

4

    

  II.3

Determining of Specific lab testing requirements

NRA

week 17

1

    

  II.4

State-approved lab contracting

Executor

week 18

2

    

  II.5

Samples and Ref. Standards permit obtaining 

Executor

week 20

1

    

  II.6

Samples and Ref. Standards shipping

MAH

week 21

2

    

  II.7

Samples and Ref. Standards custom clearance

Executor

week 23

1

    

  II.8

Optional clinical evaluation (in some countries)

Executor

week 24

8

    

  II.9

Verification of medication guidelines and drug labeling

NRA

week 32

2

    

  II.10

Verification of DHCP Letter and Communication Plan

NRA

week 32

2

    

  II.11

Approval or Query

NRA

week 33

1

   

Approval or Q&A

III

Q&A

       

  III.1

Analysis and addressing Qs to MAH

Executor

Mnth 8

1

    

  III.2

Answering with relevant documents

MAH

Mnth 8

1

    

  III.3

Official Response Evaluation

NRA

Mnth 8

1

    

  III.4

Approval or Query

NRA

Mnth 8

1

   

Approval or Q&A

IV

Approval

       

  IV.1

Market Authorization Approval

NRA

Mnth 9

1

    

  IV.2

Reporting to MAH, compliance check

Executor

Mnth 10

1

   

Approval

  IV.3

Listing in the state register

Executor

Mnth 10

1

   

Listing

F

Final Phase In-house Post-Authorization Activity

       

  F.1

Service Acceptance Certificate signing

MAH

Mnth 10

1

    

  F.2

Final Invoice

Executor

Mnth 10

1

    

  F.3

Final Payment

MAH

Mnth 10

1

    

  F.4

Contract Termination

Executor

Mnth 10

1

    

  F.5

Archiving and limiting access

Executor

Mnth 10

1

   

Archiving

 

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