SlideShare ist ein Scribd-Unternehmen logo
1 von 1
Downloaden Sie, um offline zu lesen
CTD Triangle

Regional
administrative
information
Module 1

Non-clinical
overview

Module 2

Not part
of the CTD

Clinical
overview
The CTD

Quality overall
summary

Quality
Module 3

Non-clinical
summary

Clinical
summary

Non-clinical
study reports

Clinical study
reports

Module 4

Module 5

The CTD triangle. The Common Technical Document is organized into five modules. Module 1is
region specific and modules 2, 3, 4 and 5 are intended to be common for all regions.

Weitere ähnliche Inhalte

Was ist angesagt?

Common Technical Document
Common Technical DocumentCommon Technical Document
Common Technical DocumentBindu Kshtriya
 
Common Technical Document (CTD)
Common Technical Document (CTD)Common Technical Document (CTD)
Common Technical Document (CTD)Swapnil Fernandes
 
Certificate of pharmaceutical productCoPP.pptx
Certificate of pharmaceutical productCoPP.pptxCertificate of pharmaceutical productCoPP.pptx
Certificate of pharmaceutical productCoPP.pptxsneha_pharmacist
 
Introduction to Pharma regulatory affairs
Introduction to Pharma regulatory affairsIntroduction to Pharma regulatory affairs
Introduction to Pharma regulatory affairsGIBT India
 
Anda review process
Anda review processAnda review process
Anda review processbinnz
 
Common Technical Document
Common Technical DocumentCommon Technical Document
Common Technical DocumentDr Sukanta sen
 
Bracketing and Matrixing Methods for Stability analysis
Bracketing and Matrixing Methods for Stability analysisBracketing and Matrixing Methods for Stability analysis
Bracketing and Matrixing Methods for Stability analysisSarath Chandra
 
Common technical document format
Common technical document formatCommon technical document format
Common technical document formatDev Jain
 
US and EU Submission – Comparative
US and EU Submission – ComparativeUS and EU Submission – Comparative
US and EU Submission – ComparativeGirish Swami
 
Regulatory Affairs role in Pharmaceutical Industry
Regulatory Affairs role in Pharmaceutical IndustryRegulatory Affairs role in Pharmaceutical Industry
Regulatory Affairs role in Pharmaceutical IndustryTarun Kumar Reddy
 
QUALITY MANAGEMNT SYSTEMS: Change Control (CC)
QUALITY MANAGEMNT SYSTEMS: Change Control (CC)QUALITY MANAGEMNT SYSTEMS: Change Control (CC)
QUALITY MANAGEMNT SYSTEMS: Change Control (CC)Dr Ajay Kumar Tiwari
 
ANDA regulatory approval process
ANDA regulatory approval processANDA regulatory approval process
ANDA regulatory approval processROHIT
 

Was ist angesagt? (20)

Common Technical Document
Common Technical DocumentCommon Technical Document
Common Technical Document
 
Common Technical Document (CTD)
Common Technical Document (CTD)Common Technical Document (CTD)
Common Technical Document (CTD)
 
Certificate of pharmaceutical productCoPP.pptx
Certificate of pharmaceutical productCoPP.pptxCertificate of pharmaceutical productCoPP.pptx
Certificate of pharmaceutical productCoPP.pptx
 
ACTD- ASEAN
ACTD- ASEANACTD- ASEAN
ACTD- ASEAN
 
Introduction to Pharma regulatory affairs
Introduction to Pharma regulatory affairsIntroduction to Pharma regulatory affairs
Introduction to Pharma regulatory affairs
 
Anda review process
Anda review processAnda review process
Anda review process
 
CTD and eCTD
CTD and eCTDCTD and eCTD
CTD and eCTD
 
Common Technical Document
Common Technical DocumentCommon Technical Document
Common Technical Document
 
ACTD Guidelines Overview
ACTD Guidelines OverviewACTD Guidelines Overview
ACTD Guidelines Overview
 
Bracketing and Matrixing Methods for Stability analysis
Bracketing and Matrixing Methods for Stability analysisBracketing and Matrixing Methods for Stability analysis
Bracketing and Matrixing Methods for Stability analysis
 
hatch-waxman act@amendments
hatch-waxman act@amendmentshatch-waxman act@amendments
hatch-waxman act@amendments
 
Common technical document format
Common technical document formatCommon technical document format
Common technical document format
 
505 (b) (2)
505 (b) (2)505 (b) (2)
505 (b) (2)
 
Ctd & ectd
Ctd & ectdCtd & ectd
Ctd & ectd
 
CTD Guidelines Overview
CTD Guidelines OverviewCTD Guidelines Overview
CTD Guidelines Overview
 
US and EU Submission – Comparative
US and EU Submission – ComparativeUS and EU Submission – Comparative
US and EU Submission – Comparative
 
Regulatory Affairs role in Pharmaceutical Industry
Regulatory Affairs role in Pharmaceutical IndustryRegulatory Affairs role in Pharmaceutical Industry
Regulatory Affairs role in Pharmaceutical Industry
 
QUALITY MANAGEMNT SYSTEMS: Change Control (CC)
QUALITY MANAGEMNT SYSTEMS: Change Control (CC)QUALITY MANAGEMNT SYSTEMS: Change Control (CC)
QUALITY MANAGEMNT SYSTEMS: Change Control (CC)
 
Hatch Waxman Act
Hatch Waxman ActHatch Waxman Act
Hatch Waxman Act
 
ANDA regulatory approval process
ANDA regulatory approval processANDA regulatory approval process
ANDA regulatory approval process
 

Mehr von moulai

551f350166a6c72468e7b3c59e9bcb82
551f350166a6c72468e7b3c59e9bcb82551f350166a6c72468e7b3c59e9bcb82
551f350166a6c72468e7b3c59e9bcb82moulai
 
7e y _lgwt8avrjt1wb0m7hlkz18
7e y _lgwt8avrjt1wb0m7hlkz187e y _lgwt8avrjt1wb0m7hlkz18
7e y _lgwt8avrjt1wb0m7hlkz18moulai
 
7e y _lgwt8avrjt1wb0m7hlkz18
7e y _lgwt8avrjt1wb0m7hlkz187e y _lgwt8avrjt1wb0m7hlkz18
7e y _lgwt8avrjt1wb0m7hlkz18moulai
 
7e y _lgwt8avrjt1wb0m7hlkz18(6)
7e y _lgwt8avrjt1wb0m7hlkz18(6)7e y _lgwt8avrjt1wb0m7hlkz18(6)
7e y _lgwt8avrjt1wb0m7hlkz18(6)moulai
 
7e y _lgwt8avrjt1wb0m7hlkz18(4)
7e y _lgwt8avrjt1wb0m7hlkz18(4)7e y _lgwt8avrjt1wb0m7hlkz18(4)
7e y _lgwt8avrjt1wb0m7hlkz18(4)moulai
 
7e y _lgwt8avrjt1wb0m7hlkz18(3)
7e y _lgwt8avrjt1wb0m7hlkz18(3)7e y _lgwt8avrjt1wb0m7hlkz18(3)
7e y _lgwt8avrjt1wb0m7hlkz18(3)moulai
 
7e y _lgwt8avrjt1wb0m7hlkz18(2)
7e y _lgwt8avrjt1wb0m7hlkz18(2)7e y _lgwt8avrjt1wb0m7hlkz18(2)
7e y _lgwt8avrjt1wb0m7hlkz18(2)moulai
 
7e y _lgwt8avrjt1wb0m7hlkz18
7e y _lgwt8avrjt1wb0m7hlkz187e y _lgwt8avrjt1wb0m7hlkz18
7e y _lgwt8avrjt1wb0m7hlkz18moulai
 
7e y _lgwt8avrjt1wb0m7hlkz18(3)
7e y _lgwt8avrjt1wb0m7hlkz18(3)7e y _lgwt8avrjt1wb0m7hlkz18(3)
7e y _lgwt8avrjt1wb0m7hlkz18(3)moulai
 
7e y _lgwt8avrjt1wb0m7hlkz18(2)
7e y _lgwt8avrjt1wb0m7hlkz18(2)7e y _lgwt8avrjt1wb0m7hlkz18(2)
7e y _lgwt8avrjt1wb0m7hlkz18(2)moulai
 
7e y _lgwt8avrjt1wb0m7hlkz18(1)
7e y _lgwt8avrjt1wb0m7hlkz18(1)7e y _lgwt8avrjt1wb0m7hlkz18(1)
7e y _lgwt8avrjt1wb0m7hlkz18(1)moulai
 
6 che01
6 che016 che01
6 che01moulai
 
6 che01(1)
6 che01(1)6 che01(1)
6 che01(1)moulai
 
2c9e76bb8ddf836a957e2abe3317dad1
2c9e76bb8ddf836a957e2abe3317dad12c9e76bb8ddf836a957e2abe3317dad1
2c9e76bb8ddf836a957e2abe3317dad1moulai
 
02 dm 2013
02 dm 201302 dm 2013
02 dm 2013moulai
 
01 dm 2013
01 dm 201301 dm 2013
01 dm 2013moulai
 
Bac sidahmed
Bac sidahmedBac sidahmed
Bac sidahmedmoulai
 
Correctifs cahier charges_aoni02_2013
Correctifs cahier charges_aoni02_2013Correctifs cahier charges_aoni02_2013
Correctifs cahier charges_aoni02_2013moulai
 
Lp 120925-methylphenidate
Lp 120925-methylphenidateLp 120925-methylphenidate
Lp 120925-methylphenidatemoulai
 
Dispomedicale
DispomedicaleDispomedicale
Dispomedicalemoulai
 

Mehr von moulai (20)

551f350166a6c72468e7b3c59e9bcb82
551f350166a6c72468e7b3c59e9bcb82551f350166a6c72468e7b3c59e9bcb82
551f350166a6c72468e7b3c59e9bcb82
 
7e y _lgwt8avrjt1wb0m7hlkz18
7e y _lgwt8avrjt1wb0m7hlkz187e y _lgwt8avrjt1wb0m7hlkz18
7e y _lgwt8avrjt1wb0m7hlkz18
 
7e y _lgwt8avrjt1wb0m7hlkz18
7e y _lgwt8avrjt1wb0m7hlkz187e y _lgwt8avrjt1wb0m7hlkz18
7e y _lgwt8avrjt1wb0m7hlkz18
 
7e y _lgwt8avrjt1wb0m7hlkz18(6)
7e y _lgwt8avrjt1wb0m7hlkz18(6)7e y _lgwt8avrjt1wb0m7hlkz18(6)
7e y _lgwt8avrjt1wb0m7hlkz18(6)
 
7e y _lgwt8avrjt1wb0m7hlkz18(4)
7e y _lgwt8avrjt1wb0m7hlkz18(4)7e y _lgwt8avrjt1wb0m7hlkz18(4)
7e y _lgwt8avrjt1wb0m7hlkz18(4)
 
7e y _lgwt8avrjt1wb0m7hlkz18(3)
7e y _lgwt8avrjt1wb0m7hlkz18(3)7e y _lgwt8avrjt1wb0m7hlkz18(3)
7e y _lgwt8avrjt1wb0m7hlkz18(3)
 
7e y _lgwt8avrjt1wb0m7hlkz18(2)
7e y _lgwt8avrjt1wb0m7hlkz18(2)7e y _lgwt8avrjt1wb0m7hlkz18(2)
7e y _lgwt8avrjt1wb0m7hlkz18(2)
 
7e y _lgwt8avrjt1wb0m7hlkz18
7e y _lgwt8avrjt1wb0m7hlkz187e y _lgwt8avrjt1wb0m7hlkz18
7e y _lgwt8avrjt1wb0m7hlkz18
 
7e y _lgwt8avrjt1wb0m7hlkz18(3)
7e y _lgwt8avrjt1wb0m7hlkz18(3)7e y _lgwt8avrjt1wb0m7hlkz18(3)
7e y _lgwt8avrjt1wb0m7hlkz18(3)
 
7e y _lgwt8avrjt1wb0m7hlkz18(2)
7e y _lgwt8avrjt1wb0m7hlkz18(2)7e y _lgwt8avrjt1wb0m7hlkz18(2)
7e y _lgwt8avrjt1wb0m7hlkz18(2)
 
7e y _lgwt8avrjt1wb0m7hlkz18(1)
7e y _lgwt8avrjt1wb0m7hlkz18(1)7e y _lgwt8avrjt1wb0m7hlkz18(1)
7e y _lgwt8avrjt1wb0m7hlkz18(1)
 
6 che01
6 che016 che01
6 che01
 
6 che01(1)
6 che01(1)6 che01(1)
6 che01(1)
 
2c9e76bb8ddf836a957e2abe3317dad1
2c9e76bb8ddf836a957e2abe3317dad12c9e76bb8ddf836a957e2abe3317dad1
2c9e76bb8ddf836a957e2abe3317dad1
 
02 dm 2013
02 dm 201302 dm 2013
02 dm 2013
 
01 dm 2013
01 dm 201301 dm 2013
01 dm 2013
 
Bac sidahmed
Bac sidahmedBac sidahmed
Bac sidahmed
 
Correctifs cahier charges_aoni02_2013
Correctifs cahier charges_aoni02_2013Correctifs cahier charges_aoni02_2013
Correctifs cahier charges_aoni02_2013
 
Lp 120925-methylphenidate
Lp 120925-methylphenidateLp 120925-methylphenidate
Lp 120925-methylphenidate
 
Dispomedicale
DispomedicaleDispomedicale
Dispomedicale
 

Ctd triangle

  • 1. CTD Triangle Regional administrative information Module 1 Non-clinical overview Module 2 Not part of the CTD Clinical overview The CTD Quality overall summary Quality Module 3 Non-clinical summary Clinical summary Non-clinical study reports Clinical study reports Module 4 Module 5 The CTD triangle. The Common Technical Document is organized into five modules. Module 1is region specific and modules 2, 3, 4 and 5 are intended to be common for all regions.