SlideShare a Scribd company logo
1 of 13
Download to read offline
REGULATORY AFFAIRS
NON CLINICAL DRUG DEVELOPMENT:
GLOBAL SUBMISSION OF NDA
Presented by
ABDUL NAIM
M.Pharm Pharmaceutics Department
Nargund college of pharmacy
NEW DRUG APPLICATION (NDA):
The New Drug Application is the vehicle through which the drug
sponsors formally propose FDA or DCGI to approve a new
investigational drug for sale and marketing after phase IIIA Pivot
trials.
The official definition of New Drug is in sec 201(p) of Federal Drug,
Food and Cosmetics Act as;
Any new drug, the composition of which is such that it is not
recognized among experts qualified by scientific training as safe and
effective for use under prescribed, recommended or suggested
conditions.
The following letter codes describe the review priority of the drug;
S-Standard review:- For drugs similar to currently available drug.
P-Priority review:- For drugs that represent significant advances over
existing treatments.
Classification of drugs in NDA:-
Center of drug evaluation and research (CDER) classifies new drug
applications according to the type of drug being submitted and its intended
use;
A) New molecular entity.
B) New salt of previously approved drug.
C) New formulation of previously approved drug.
D) New combination of two or more drug.
E) Already marketed drug product-Duplication.
F) New indication (claim) for already marketed drug.
G) Already marketed drug product (no previous approved NDA)
In US following 4 type of applications are submitted for approval of drug for
marketing depending upon the type and nature of the drug;
A) New drug application (NDA).
B) Biological License Application (BLA).
C) Application u/s 505(b)(2) Paper NDA.
D) Supplemental New Drug Application (SNDA).
FORMAT and content of NDA:-
The application is required to be submitted in common technical document
format with the following different sections;
1. FDA from 356h
2. User free cover sheet (FDA from 3397)
3. Cover latter (comprehensive table of contents for modules 1 to 5)
4. Summary
5. Chemistry, Manufacturing and Control
6. Samples, method validation package and labeling
7. Nonclinical pharmacology and toxicology
8. Human pharmacokinetics and bioavailability
9. Microbiology (for anti-microbial drugs only)
10. Statistical methods and analysis of clinical data
11. Safety update report (typically submitted 120 days after NDA submission)
12. Statement regarding compliance to IRB and Informed Consent
requirements
13. Case Report Tabulations
14. Case Report Forms
15. Patent information and certification
16. Other information
General requirements for filing NDA:-
The new NDA regulations require the application to be submitted in 2
copies;
A) An Archival copy:- It is a complete copy of application submission that
serves as its permanent record.
B) A Review copy:- It is divided into 6 technical sections;
1. Chemistry, Manufacturing and Controls (CMC)
2. Nonclinical pharmacology and toxicology
3. Human pharmacokinetics and Bioavailability
4. Microbiology
5. Clinical data
6. Statistical
On receipt of NDA, the CDER stamps with a receipt dare to enable FDA to
forward action within 180 days called ‘Review Clock’ under Review Time
Frames (21 CFR 314.100).The FDA assigns the application for review.
The FDA has to intimate the applicant if it is incomplete within 60 days
according to Filing Time Frames (21 CFR 314.101).
FDA notifies the sponsor of its completion/ incompletion and if complete
sends it for secondary review process.
FDA inspects the manufacturing facilities for the drug, it may also inspect
sample of clinical trial locations to verify the accuracy of data submitted.
NDA REVIEW CHART
Throughout the process FDA and sponsor communicate through in
person meetings, telephone conferences, fax etc… to seek clarification if
necessary. Once all reviews are complete; the divisional director
evaluates the reviews and makes FDAs decision.
The FDA MAY;
• Approve the drug for marketing.
• Approve the drug with condition when problem exist with the
application that needs to be addressed before approval.
• Refuse to approve the drug, when it may require additional research or
reformulation of the drug product.
NDA PROCESS IN INDIA:-
In India, New Drug is defined under Rule 122-E of Drugs and Cosmetics
Act as;
A) A drug which has not been used in the country to any significant
extent under various conditions.
B) A drug already approved by DCGI for certain claims which is now
proposed to be marketed with new claims like indications, dosage,
dosage form etc…
C) A fixed dose combination of two individually approved drug being
combined for the first time in a fixed ratio or new ratio in already
marketed combination.
D) All vaccines are considered as new drugs.
E) A new drug continues to be considered as new drug for a period of 4
years from its approval or its inclusion in India Pharmacopoeia.
After successful finishing of clinical trials, the applicant seeking for
approval to manufacture a new drug requires to submit application on
form 44 along with data as given in Appendix I to Schedule Y of Rules 1945
to DCGI who grants its approval in form 46 or 46-A.
Further, the applicant is required to submit evidence that the drug for
manufacturing approval already has been approved by DCGI.
In his name while applying to manufacture a new drug to State Licensing
Authority. Thus the applicant is required to obtain necessary approval
from DCGI as well as SLA for manufacturing a new drug for sale purposes
in India.
The approval issued is ‘manufacture for sale’ rather than ‘marketing
approval’ as per the practice world over.
PERMISSION TO MANUFACTURE A NEW DRUG:-
• Brief introduction of the new drug.
• Chemical and pharmacological information.
• Animal pharmacology and toxicology.
• Human/ clinical pharmacology (phase I).
• Exploratory clinical trials (phase II).
• Confirmatory clinical trials (phase III).
• Bio-availability, dissolution and stability study data.
• Regulatory status in other country.
• Application for test license.
• Marketing information.

More Related Content

What's hot

Cmc, post approval and regulation
Cmc, post approval and regulationCmc, post approval and regulation
Cmc, post approval and regulationHimal Barakoti
 
1.BIOEQUIVALENCE AND DRUG PRODUCT ASSESSMENT.pptx
1.BIOEQUIVALENCE AND DRUG PRODUCT ASSESSMENT.pptx1.BIOEQUIVALENCE AND DRUG PRODUCT ASSESSMENT.pptx
1.BIOEQUIVALENCE AND DRUG PRODUCT ASSESSMENT.pptxKrishnapriyaVH1
 
industry and FDA liaisons
industry and FDA liaisonsindustry and FDA liaisons
industry and FDA liaisonsfouza ameer
 
Investigation of medicinal product dossier (IMPD)
Investigation of medicinal product dossier (IMPD)Investigation of medicinal product dossier (IMPD)
Investigation of medicinal product dossier (IMPD)Himal Barakoti
 
Seminar on NDA approval process.pptx
Seminar on NDA approval process.pptxSeminar on NDA approval process.pptx
Seminar on NDA approval process.pptxPawanDhamala1
 
Regulatory requirements for API and Biologics
Regulatory requirements for API and BiologicsRegulatory requirements for API and Biologics
Regulatory requirements for API and BiologicsSimranDhiman12
 
REGULATIONS FOR COMBINATION PRODUCTS AND MEDICAL DEVICES
REGULATIONS FOR COMBINATION PRODUCTS AND MEDICAL DEVICESREGULATIONS FOR COMBINATION PRODUCTS AND MEDICAL DEVICES
REGULATIONS FOR COMBINATION PRODUCTS AND MEDICAL DEVICESArunpandiyan59
 
Investigation of medicinal product dossier (IMPD) and investigational brochur...
Investigation of medicinal product dossier (IMPD) and investigational brochur...Investigation of medicinal product dossier (IMPD) and investigational brochur...
Investigation of medicinal product dossier (IMPD) and investigational brochur...Arif Nadaf
 
API, BIOLOGICS,NOVEL,THERAPIES........pptx
API, BIOLOGICS,NOVEL,THERAPIES........pptxAPI, BIOLOGICS,NOVEL,THERAPIES........pptx
API, BIOLOGICS,NOVEL,THERAPIES........pptxPawanDhamala1
 
Regulatory requirement of EU, MHRA and TGA
Regulatory requirement of EU, MHRA and TGARegulatory requirement of EU, MHRA and TGA
Regulatory requirement of EU, MHRA and TGAHimal Barakoti
 
Current Goods Manufacturing Practice & Industrial Management
Current Goods Manufacturing Practice & Industrial ManagementCurrent Goods Manufacturing Practice & Industrial Management
Current Goods Manufacturing Practice & Industrial ManagementLukman N Kerur
 
Therapeutics goods administration & Row Countries
Therapeutics goods administration & Row CountriesTherapeutics goods administration & Row Countries
Therapeutics goods administration & Row CountriesMaan Singh
 
CMC, post approval regulatory affairs, etc
CMC, post approval regulatory affairs, etcCMC, post approval regulatory affairs, etc
CMC, post approval regulatory affairs, etcJayeshRajput7
 
Barriers to protein and peptide delivery.pptx
Barriers to protein and peptide delivery.pptxBarriers to protein and peptide delivery.pptx
Barriers to protein and peptide delivery.pptxMeghajoshi86
 
Regulation for combination product
Regulation for combination productRegulation for combination product
Regulation for combination productAkashYadav283
 
Bioequivalence and drug product assessment
Bioequivalence and drug product assessmentBioequivalence and drug product assessment
Bioequivalence and drug product assessmentGauravchaudhary199
 

What's hot (20)

Cmc, post approval and regulation
Cmc, post approval and regulationCmc, post approval and regulation
Cmc, post approval and regulation
 
1.BIOEQUIVALENCE AND DRUG PRODUCT ASSESSMENT.pptx
1.BIOEQUIVALENCE AND DRUG PRODUCT ASSESSMENT.pptx1.BIOEQUIVALENCE AND DRUG PRODUCT ASSESSMENT.pptx
1.BIOEQUIVALENCE AND DRUG PRODUCT ASSESSMENT.pptx
 
Drug product perfomance in vitro
Drug product perfomance in vitroDrug product perfomance in vitro
Drug product perfomance in vitro
 
industry and FDA liaisons
industry and FDA liaisonsindustry and FDA liaisons
industry and FDA liaisons
 
Investigation of medicinal product dossier (IMPD)
Investigation of medicinal product dossier (IMPD)Investigation of medicinal product dossier (IMPD)
Investigation of medicinal product dossier (IMPD)
 
Seminar on NDA approval process.pptx
Seminar on NDA approval process.pptxSeminar on NDA approval process.pptx
Seminar on NDA approval process.pptx
 
Regulatory requirements for API and Biologics
Regulatory requirements for API and BiologicsRegulatory requirements for API and Biologics
Regulatory requirements for API and Biologics
 
REGULATIONS FOR COMBINATION PRODUCTS AND MEDICAL DEVICES
REGULATIONS FOR COMBINATION PRODUCTS AND MEDICAL DEVICESREGULATIONS FOR COMBINATION PRODUCTS AND MEDICAL DEVICES
REGULATIONS FOR COMBINATION PRODUCTS AND MEDICAL DEVICES
 
Investigation of medicinal product dossier (IMPD) and investigational brochur...
Investigation of medicinal product dossier (IMPD) and investigational brochur...Investigation of medicinal product dossier (IMPD) and investigational brochur...
Investigation of medicinal product dossier (IMPD) and investigational brochur...
 
API, BIOLOGICS,NOVEL,THERAPIES........pptx
API, BIOLOGICS,NOVEL,THERAPIES........pptxAPI, BIOLOGICS,NOVEL,THERAPIES........pptx
API, BIOLOGICS,NOVEL,THERAPIES........pptx
 
Regulatory requirement of EU, MHRA and TGA
Regulatory requirement of EU, MHRA and TGARegulatory requirement of EU, MHRA and TGA
Regulatory requirement of EU, MHRA and TGA
 
Current Goods Manufacturing Practice & Industrial Management
Current Goods Manufacturing Practice & Industrial ManagementCurrent Goods Manufacturing Practice & Industrial Management
Current Goods Manufacturing Practice & Industrial Management
 
Therapeutics goods administration & Row Countries
Therapeutics goods administration & Row CountriesTherapeutics goods administration & Row Countries
Therapeutics goods administration & Row Countries
 
CMC, post approval regulatory affairs, etc
CMC, post approval regulatory affairs, etcCMC, post approval regulatory affairs, etc
CMC, post approval regulatory affairs, etc
 
clinical trials
clinical trialsclinical trials
clinical trials
 
Barriers to protein and peptide delivery.pptx
Barriers to protein and peptide delivery.pptxBarriers to protein and peptide delivery.pptx
Barriers to protein and peptide delivery.pptx
 
Preformulation concept
Preformulation conceptPreformulation concept
Preformulation concept
 
Regulation for combination product
Regulation for combination productRegulation for combination product
Regulation for combination product
 
Industry and fda laision &
Industry and fda laision &Industry and fda laision &
Industry and fda laision &
 
Bioequivalence and drug product assessment
Bioequivalence and drug product assessmentBioequivalence and drug product assessment
Bioequivalence and drug product assessment
 

Similar to global submission of NDA .pptx

IND INDA ANDA Application
IND INDA ANDA ApplicationIND INDA ANDA Application
IND INDA ANDA ApplicationRoshan Bodhe
 
Global Subbmission of IND, NDA, ANDA
Global Subbmission of IND, NDA, ANDA Global Subbmission of IND, NDA, ANDA
Global Subbmission of IND, NDA, ANDA Maruthi.N
 
Global submission of IND, NDA ANDA ( Santosh Kumar) (1).pptx
Global submission of IND, NDA ANDA ( Santosh Kumar) (1).pptxGlobal submission of IND, NDA ANDA ( Santosh Kumar) (1).pptx
Global submission of IND, NDA ANDA ( Santosh Kumar) (1).pptxSANTOSHKUMAR506229
 
Global Submission of IND& NDA pptx
Global Submission of IND& NDA pptxGlobal Submission of IND& NDA pptx
Global Submission of IND& NDA pptxchitrangpatil700
 
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...Audumbar Mali
 
New Drug Application In India and US.
New Drug Application In India and US. New Drug Application In India and US.
New Drug Application In India and US. sopansanap1
 
NDA and ANDA regulatory approval process
NDA and ANDA regulatory approval processNDA and ANDA regulatory approval process
NDA and ANDA regulatory approval processNilesh Gawade
 
NON CLINICAL ncdd-210117181652.pptx
NON CLINICAL ncdd-210117181652.pptxNON CLINICAL ncdd-210117181652.pptx
NON CLINICAL ncdd-210117181652.pptxDhanaa Dhoni
 
NON CLINICAL ncdd-210117181652.pptx
NON CLINICAL ncdd-210117181652.pptxNON CLINICAL ncdd-210117181652.pptx
NON CLINICAL ncdd-210117181652.pptxDhanaa Dhoni
 
Drug approval process
Drug approval processDrug approval process
Drug approval processLitashaGandhi
 
INVESTIGATIONAL NEW DRUG APPLICATION(IND)
INVESTIGATIONAL NEW DRUG APPLICATION(IND) INVESTIGATIONAL NEW DRUG APPLICATION(IND)
INVESTIGATIONAL NEW DRUG APPLICATION(IND) monika maan
 
Non clinical drug development
Non clinical drug developmentNon clinical drug development
Non clinical drug developmentMahesh Kesalkar
 
Abbreviated New Drug Application ANDA ppt
Abbreviated New Drug Application ANDA pptAbbreviated New Drug Application ANDA ppt
Abbreviated New Drug Application ANDA pptAkanksha Puri
 
Regulation Governing Clinical Trials In India,USA and Europe.
Regulation Governing Clinical Trials In India,USA and Europe.  Regulation Governing Clinical Trials In India,USA and Europe.
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
 
2.IND AND ANDA.pptx
2.IND AND ANDA.pptx2.IND AND ANDA.pptx
2.IND AND ANDA.pptxbrahmaiahmph
 
NDA Application.pptx
NDA Application.pptxNDA Application.pptx
NDA Application.pptxVenugopal N
 

Similar to global submission of NDA .pptx (20)

IND INDA ANDA Application
IND INDA ANDA ApplicationIND INDA ANDA Application
IND INDA ANDA Application
 
Global Subbmission of IND, NDA, ANDA
Global Subbmission of IND, NDA, ANDA Global Subbmission of IND, NDA, ANDA
Global Subbmission of IND, NDA, ANDA
 
Global submission of IND, NDA ANDA ( Santosh Kumar) (1).pptx
Global submission of IND, NDA ANDA ( Santosh Kumar) (1).pptxGlobal submission of IND, NDA ANDA ( Santosh Kumar) (1).pptx
Global submission of IND, NDA ANDA ( Santosh Kumar) (1).pptx
 
NDA IND and ANDA
NDA IND and ANDANDA IND and ANDA
NDA IND and ANDA
 
Global Submission of IND& NDA pptx
Global Submission of IND& NDA pptxGlobal Submission of IND& NDA pptx
Global Submission of IND& NDA pptx
 
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
 
New Drug Application In India and US.
New Drug Application In India and US. New Drug Application In India and US.
New Drug Application In India and US.
 
NDA and ANDA regulatory approval process
NDA and ANDA regulatory approval processNDA and ANDA regulatory approval process
NDA and ANDA regulatory approval process
 
NON CLINICAL ncdd-210117181652.pptx
NON CLINICAL ncdd-210117181652.pptxNON CLINICAL ncdd-210117181652.pptx
NON CLINICAL ncdd-210117181652.pptx
 
NON CLINICAL ncdd-210117181652.pptx
NON CLINICAL ncdd-210117181652.pptxNON CLINICAL ncdd-210117181652.pptx
NON CLINICAL ncdd-210117181652.pptx
 
Drug approval process
Drug approval processDrug approval process
Drug approval process
 
INVESTIGATIONAL NEW DRUG APPLICATION(IND)
INVESTIGATIONAL NEW DRUG APPLICATION(IND) INVESTIGATIONAL NEW DRUG APPLICATION(IND)
INVESTIGATIONAL NEW DRUG APPLICATION(IND)
 
Non clinical drug development
Non clinical drug developmentNon clinical drug development
Non clinical drug development
 
Abbreviated New Drug Application ANDA ppt
Abbreviated New Drug Application ANDA pptAbbreviated New Drug Application ANDA ppt
Abbreviated New Drug Application ANDA ppt
 
Regulation Governing Clinical Trials In India,USA and Europe.
Regulation Governing Clinical Trials In India,USA and Europe.  Regulation Governing Clinical Trials In India,USA and Europe.
Regulation Governing Clinical Trials In India,USA and Europe.
 
2.IND AND ANDA.pptx
2.IND AND ANDA.pptx2.IND AND ANDA.pptx
2.IND AND ANDA.pptx
 
Sem 2 nda
Sem 2 ndaSem 2 nda
Sem 2 nda
 
Drug regulation
Drug regulationDrug regulation
Drug regulation
 
Regulation on new drugs
Regulation on new drugsRegulation on new drugs
Regulation on new drugs
 
NDA Application.pptx
NDA Application.pptxNDA Application.pptx
NDA Application.pptx
 

More from AbdulNaim14

informed consent process and procedure .pptx
informed consent process and procedure .pptxinformed consent process and procedure .pptx
informed consent process and procedure .pptxAbdulNaim14
 
ICH GUIDELINES.pptx
ICH GUIDELINES.pptxICH GUIDELINES.pptx
ICH GUIDELINES.pptxAbdulNaim14
 
HECKEL PLOT CEUTICS .pptx
HECKEL PLOT CEUTICS .pptxHECKEL PLOT CEUTICS .pptx
HECKEL PLOT CEUTICS .pptxAbdulNaim14
 
global submission of ANDA .pptx
global submission of ANDA .pptxglobal submission of ANDA .pptx
global submission of ANDA .pptxAbdulNaim14
 
post approval regulatory affairs
post approval regulatory affairspost approval regulatory affairs
post approval regulatory affairsAbdulNaim14
 
types of validation
types of validation types of validation
types of validation AbdulNaim14
 

More from AbdulNaim14 (6)

informed consent process and procedure .pptx
informed consent process and procedure .pptxinformed consent process and procedure .pptx
informed consent process and procedure .pptx
 
ICH GUIDELINES.pptx
ICH GUIDELINES.pptxICH GUIDELINES.pptx
ICH GUIDELINES.pptx
 
HECKEL PLOT CEUTICS .pptx
HECKEL PLOT CEUTICS .pptxHECKEL PLOT CEUTICS .pptx
HECKEL PLOT CEUTICS .pptx
 
global submission of ANDA .pptx
global submission of ANDA .pptxglobal submission of ANDA .pptx
global submission of ANDA .pptx
 
post approval regulatory affairs
post approval regulatory affairspost approval regulatory affairs
post approval regulatory affairs
 
types of validation
types of validation types of validation
types of validation
 

Recently uploaded

The Emergence of Legislative Behavior in the Colombian Congress
The Emergence of Legislative Behavior in the Colombian CongressThe Emergence of Legislative Behavior in the Colombian Congress
The Emergence of Legislative Behavior in the Colombian CongressMaria Paula Aroca
 
Healthy Minds, Flourishing Lives: A Philosophical Approach to Mental Health a...
Healthy Minds, Flourishing Lives: A Philosophical Approach to Mental Health a...Healthy Minds, Flourishing Lives: A Philosophical Approach to Mental Health a...
Healthy Minds, Flourishing Lives: A Philosophical Approach to Mental Health a...Osopher
 
(Part 3) CHILDREN'S DISABILITIES AND EXCEPTIONALITIES.pdf
(Part 3) CHILDREN'S DISABILITIES AND EXCEPTIONALITIES.pdf(Part 3) CHILDREN'S DISABILITIES AND EXCEPTIONALITIES.pdf
(Part 3) CHILDREN'S DISABILITIES AND EXCEPTIONALITIES.pdfMJDuyan
 
Jason Potel In Media Res Media Component
Jason Potel In Media Res Media ComponentJason Potel In Media Res Media Component
Jason Potel In Media Res Media ComponentInMediaRes1
 
Jordan Chrietzberg In Media Res Media Component
Jordan Chrietzberg In Media Res Media ComponentJordan Chrietzberg In Media Res Media Component
Jordan Chrietzberg In Media Res Media ComponentInMediaRes1
 
The role of Geography in climate education: science and active citizenship
The role of Geography in climate education: science and active citizenshipThe role of Geography in climate education: science and active citizenship
The role of Geography in climate education: science and active citizenshipKarl Donert
 
(Part 2) CHILDREN'S DISABILITIES AND EXCEPTIONALITIES.pdf
(Part 2) CHILDREN'S DISABILITIES AND EXCEPTIONALITIES.pdf(Part 2) CHILDREN'S DISABILITIES AND EXCEPTIONALITIES.pdf
(Part 2) CHILDREN'S DISABILITIES AND EXCEPTIONALITIES.pdfMJDuyan
 
18. Training and prunning of horicultural crops.pptx
18. Training and prunning of horicultural crops.pptx18. Training and prunning of horicultural crops.pptx
18. Training and prunning of horicultural crops.pptxUmeshTimilsina1
 
How to create _name_search function in odoo 17
How to create _name_search function in odoo 17How to create _name_search function in odoo 17
How to create _name_search function in odoo 17Celine George
 
DiskStorage_BasicFileStructuresandHashing.pdf
DiskStorage_BasicFileStructuresandHashing.pdfDiskStorage_BasicFileStructuresandHashing.pdf
DiskStorage_BasicFileStructuresandHashing.pdfChristalin Nelson
 
How to Share Dashboard in the Odoo 17 ERP
How to Share Dashboard in the Odoo 17 ERPHow to Share Dashboard in the Odoo 17 ERP
How to Share Dashboard in the Odoo 17 ERPCeline George
 
What is Property Fields in Odoo 17 ERP Module
What is Property Fields in Odoo 17 ERP ModuleWhat is Property Fields in Odoo 17 ERP Module
What is Property Fields in Odoo 17 ERP ModuleCeline George
 
The Shop Floor Overview in the Odoo 17 ERP
The Shop Floor Overview in the Odoo 17 ERPThe Shop Floor Overview in the Odoo 17 ERP
The Shop Floor Overview in the Odoo 17 ERPCeline George
 
Sulphonamides, mechanisms and their uses
Sulphonamides, mechanisms and their usesSulphonamides, mechanisms and their uses
Sulphonamides, mechanisms and their usesVijayaLaxmi84
 
4.4.24 Economic Precarity and Global Economic Forces.pptx
4.4.24 Economic Precarity and Global Economic Forces.pptx4.4.24 Economic Precarity and Global Economic Forces.pptx
4.4.24 Economic Precarity and Global Economic Forces.pptxmary850239
 
4.9.24 School Desegregation in Boston.pptx
4.9.24 School Desegregation in Boston.pptx4.9.24 School Desegregation in Boston.pptx
4.9.24 School Desegregation in Boston.pptxmary850239
 
Shark introduction Morphology and its behaviour characteristics
Shark introduction Morphology and its behaviour characteristicsShark introduction Morphology and its behaviour characteristics
Shark introduction Morphology and its behaviour characteristicsArubSultan
 

Recently uploaded (20)

Chi-Square Test Non Parametric Test Categorical Variable
Chi-Square Test Non Parametric Test Categorical VariableChi-Square Test Non Parametric Test Categorical Variable
Chi-Square Test Non Parametric Test Categorical Variable
 
The Emergence of Legislative Behavior in the Colombian Congress
The Emergence of Legislative Behavior in the Colombian CongressThe Emergence of Legislative Behavior in the Colombian Congress
The Emergence of Legislative Behavior in the Colombian Congress
 
Healthy Minds, Flourishing Lives: A Philosophical Approach to Mental Health a...
Healthy Minds, Flourishing Lives: A Philosophical Approach to Mental Health a...Healthy Minds, Flourishing Lives: A Philosophical Approach to Mental Health a...
Healthy Minds, Flourishing Lives: A Philosophical Approach to Mental Health a...
 
(Part 3) CHILDREN'S DISABILITIES AND EXCEPTIONALITIES.pdf
(Part 3) CHILDREN'S DISABILITIES AND EXCEPTIONALITIES.pdf(Part 3) CHILDREN'S DISABILITIES AND EXCEPTIONALITIES.pdf
(Part 3) CHILDREN'S DISABILITIES AND EXCEPTIONALITIES.pdf
 
Jason Potel In Media Res Media Component
Jason Potel In Media Res Media ComponentJason Potel In Media Res Media Component
Jason Potel In Media Res Media Component
 
Jordan Chrietzberg In Media Res Media Component
Jordan Chrietzberg In Media Res Media ComponentJordan Chrietzberg In Media Res Media Component
Jordan Chrietzberg In Media Res Media Component
 
The role of Geography in climate education: science and active citizenship
The role of Geography in climate education: science and active citizenshipThe role of Geography in climate education: science and active citizenship
The role of Geography in climate education: science and active citizenship
 
Mattingly "AI & Prompt Design" - Introduction to Machine Learning"
Mattingly "AI & Prompt Design" - Introduction to Machine Learning"Mattingly "AI & Prompt Design" - Introduction to Machine Learning"
Mattingly "AI & Prompt Design" - Introduction to Machine Learning"
 
(Part 2) CHILDREN'S DISABILITIES AND EXCEPTIONALITIES.pdf
(Part 2) CHILDREN'S DISABILITIES AND EXCEPTIONALITIES.pdf(Part 2) CHILDREN'S DISABILITIES AND EXCEPTIONALITIES.pdf
(Part 2) CHILDREN'S DISABILITIES AND EXCEPTIONALITIES.pdf
 
18. Training and prunning of horicultural crops.pptx
18. Training and prunning of horicultural crops.pptx18. Training and prunning of horicultural crops.pptx
18. Training and prunning of horicultural crops.pptx
 
How to create _name_search function in odoo 17
How to create _name_search function in odoo 17How to create _name_search function in odoo 17
How to create _name_search function in odoo 17
 
DiskStorage_BasicFileStructuresandHashing.pdf
DiskStorage_BasicFileStructuresandHashing.pdfDiskStorage_BasicFileStructuresandHashing.pdf
DiskStorage_BasicFileStructuresandHashing.pdf
 
How to Share Dashboard in the Odoo 17 ERP
How to Share Dashboard in the Odoo 17 ERPHow to Share Dashboard in the Odoo 17 ERP
How to Share Dashboard in the Odoo 17 ERP
 
What is Property Fields in Odoo 17 ERP Module
What is Property Fields in Odoo 17 ERP ModuleWhat is Property Fields in Odoo 17 ERP Module
What is Property Fields in Odoo 17 ERP Module
 
The Shop Floor Overview in the Odoo 17 ERP
The Shop Floor Overview in the Odoo 17 ERPThe Shop Floor Overview in the Odoo 17 ERP
The Shop Floor Overview in the Odoo 17 ERP
 
Sulphonamides, mechanisms and their uses
Sulphonamides, mechanisms and their usesSulphonamides, mechanisms and their uses
Sulphonamides, mechanisms and their uses
 
4.4.24 Economic Precarity and Global Economic Forces.pptx
4.4.24 Economic Precarity and Global Economic Forces.pptx4.4.24 Economic Precarity and Global Economic Forces.pptx
4.4.24 Economic Precarity and Global Economic Forces.pptx
 
4.9.24 School Desegregation in Boston.pptx
4.9.24 School Desegregation in Boston.pptx4.9.24 School Desegregation in Boston.pptx
4.9.24 School Desegregation in Boston.pptx
 
Shark introduction Morphology and its behaviour characteristics
Shark introduction Morphology and its behaviour characteristicsShark introduction Morphology and its behaviour characteristics
Shark introduction Morphology and its behaviour characteristics
 
Israel Genealogy Research Assoc. April 2024 Database Release
Israel Genealogy Research Assoc. April 2024 Database ReleaseIsrael Genealogy Research Assoc. April 2024 Database Release
Israel Genealogy Research Assoc. April 2024 Database Release
 

global submission of NDA .pptx

  • 1. REGULATORY AFFAIRS NON CLINICAL DRUG DEVELOPMENT: GLOBAL SUBMISSION OF NDA Presented by ABDUL NAIM M.Pharm Pharmaceutics Department Nargund college of pharmacy
  • 2. NEW DRUG APPLICATION (NDA): The New Drug Application is the vehicle through which the drug sponsors formally propose FDA or DCGI to approve a new investigational drug for sale and marketing after phase IIIA Pivot trials. The official definition of New Drug is in sec 201(p) of Federal Drug, Food and Cosmetics Act as; Any new drug, the composition of which is such that it is not recognized among experts qualified by scientific training as safe and effective for use under prescribed, recommended or suggested conditions.
  • 3. The following letter codes describe the review priority of the drug; S-Standard review:- For drugs similar to currently available drug. P-Priority review:- For drugs that represent significant advances over existing treatments. Classification of drugs in NDA:- Center of drug evaluation and research (CDER) classifies new drug applications according to the type of drug being submitted and its intended use; A) New molecular entity. B) New salt of previously approved drug. C) New formulation of previously approved drug. D) New combination of two or more drug. E) Already marketed drug product-Duplication.
  • 4. F) New indication (claim) for already marketed drug. G) Already marketed drug product (no previous approved NDA) In US following 4 type of applications are submitted for approval of drug for marketing depending upon the type and nature of the drug; A) New drug application (NDA). B) Biological License Application (BLA). C) Application u/s 505(b)(2) Paper NDA. D) Supplemental New Drug Application (SNDA).
  • 5. FORMAT and content of NDA:- The application is required to be submitted in common technical document format with the following different sections; 1. FDA from 356h 2. User free cover sheet (FDA from 3397) 3. Cover latter (comprehensive table of contents for modules 1 to 5) 4. Summary 5. Chemistry, Manufacturing and Control 6. Samples, method validation package and labeling 7. Nonclinical pharmacology and toxicology 8. Human pharmacokinetics and bioavailability
  • 6. 9. Microbiology (for anti-microbial drugs only) 10. Statistical methods and analysis of clinical data 11. Safety update report (typically submitted 120 days after NDA submission) 12. Statement regarding compliance to IRB and Informed Consent requirements 13. Case Report Tabulations 14. Case Report Forms 15. Patent information and certification 16. Other information
  • 7. General requirements for filing NDA:- The new NDA regulations require the application to be submitted in 2 copies; A) An Archival copy:- It is a complete copy of application submission that serves as its permanent record. B) A Review copy:- It is divided into 6 technical sections; 1. Chemistry, Manufacturing and Controls (CMC) 2. Nonclinical pharmacology and toxicology 3. Human pharmacokinetics and Bioavailability 4. Microbiology 5. Clinical data 6. Statistical
  • 8. On receipt of NDA, the CDER stamps with a receipt dare to enable FDA to forward action within 180 days called ‘Review Clock’ under Review Time Frames (21 CFR 314.100).The FDA assigns the application for review. The FDA has to intimate the applicant if it is incomplete within 60 days according to Filing Time Frames (21 CFR 314.101). FDA notifies the sponsor of its completion/ incompletion and if complete sends it for secondary review process. FDA inspects the manufacturing facilities for the drug, it may also inspect sample of clinical trial locations to verify the accuracy of data submitted.
  • 10. Throughout the process FDA and sponsor communicate through in person meetings, telephone conferences, fax etc… to seek clarification if necessary. Once all reviews are complete; the divisional director evaluates the reviews and makes FDAs decision. The FDA MAY; • Approve the drug for marketing. • Approve the drug with condition when problem exist with the application that needs to be addressed before approval. • Refuse to approve the drug, when it may require additional research or reformulation of the drug product.
  • 11. NDA PROCESS IN INDIA:- In India, New Drug is defined under Rule 122-E of Drugs and Cosmetics Act as; A) A drug which has not been used in the country to any significant extent under various conditions. B) A drug already approved by DCGI for certain claims which is now proposed to be marketed with new claims like indications, dosage, dosage form etc… C) A fixed dose combination of two individually approved drug being combined for the first time in a fixed ratio or new ratio in already marketed combination. D) All vaccines are considered as new drugs. E) A new drug continues to be considered as new drug for a period of 4 years from its approval or its inclusion in India Pharmacopoeia.
  • 12. After successful finishing of clinical trials, the applicant seeking for approval to manufacture a new drug requires to submit application on form 44 along with data as given in Appendix I to Schedule Y of Rules 1945 to DCGI who grants its approval in form 46 or 46-A. Further, the applicant is required to submit evidence that the drug for manufacturing approval already has been approved by DCGI. In his name while applying to manufacture a new drug to State Licensing Authority. Thus the applicant is required to obtain necessary approval from DCGI as well as SLA for manufacturing a new drug for sale purposes in India. The approval issued is ‘manufacture for sale’ rather than ‘marketing approval’ as per the practice world over.
  • 13. PERMISSION TO MANUFACTURE A NEW DRUG:- • Brief introduction of the new drug. • Chemical and pharmacological information. • Animal pharmacology and toxicology. • Human/ clinical pharmacology (phase I). • Exploratory clinical trials (phase II). • Confirmatory clinical trials (phase III). • Bio-availability, dissolution and stability study data. • Regulatory status in other country. • Application for test license. • Marketing information.