The document outlines the NDA (New Drug Application) approval process, detailing the requirements for submission to the FDA after the completion of clinical testing. It describes the necessary components of an NDA, including safety and efficacy data, clinical study results, and the format for application copies. Additionally, it explains the review process, including classification of submissions and responses from the FDA such as approval or deficiencies that need to be addressed.

1. Seminar on NDA approval
process
SUBJECT- REGULATORYAFFAIRS
SUMMITTED BY: SUBMITTED TO:
Becare Dkhar Asst. Prof. Srilatha.K.S
1st sem m.pharm
Department of Pharmaceutics

2. CONTENTS
 INTRODUCTION
 HISTORY
 NDA APPROVAL PROCESS

3. INTRODUCTION
 After the sponsor has completed all non clinical
and clinical testing which is necessary to
demonstrate the safety and effectiveness of the
drug, the test results must be compiled in an
NDA for submission to FDA
 It is a regulatory mechanism that is designed to
give FDA sufficient information to make a
meaningful evaluation of new drug.

4.  New drugs are drug that contains as its
active ingredient a new chemical entity
would be considered to be a new drug
 All definitions for a new drug appear in
the Code Of Federal Regulations for a
new drug entity.

5. NDA APPROVAL PROCESS
 The information of drug ’s safety and
efficacy collected during the animal and
human trials during the IND process
becomes part of NDA application
 NDA must be submitted complete in
proper form and with all critical data

6. All NDA’S must contain the following
information
 Index
 Summary
 Chemistry, Manufacturing and Control
 Samples, Methods Validation Package and
Labeling
 Non clinical Pharmacology and Toxicology
 Human Pharmacokinetics and Bioavailability

7.  Microbiology ( for anti-microbial drugs only
 Clinical Data
 Safety Update report ( typically submitted 120
days after the NDA’s submission )
 Statistical
 Case Report Tabulations
 Case Report Forms
 Patent Information

8.  Patent Certification &
 Other Information
FORMAT OFAPPLICATION
 3 copies of the application are required:
Archival copy
Review copy
Field copy
1. Archival copy:
It is a complete copy of the application

9.  2. Review copy
Include the information needed by each review
discipline for its evaluation
 Quality
 Non clinical
 Clinical – safety & efficacy documents for clinical
reviewer
 Clinical – safety & efficacy documents for statistical
reviewer
 Clinical – clinical pharmacology &
pharmacokinetics documents

10.  Clinical – clinical microbiology documents
3. Field copy
 Separately bound copy of the quality section. It is
directly send to the appropriate field office.
 FDA will maintain guidance documents on the
format & content of applications to assist applicants
in their preparation.

11. Application form:
The applicant shall submit a completed & signed
application form that contains:
 The name & address of the applicant
 The date of the application,
 The application number if previously issued
 The name of the product , including its
established, proprietary, code & chemical names

12.  The dosage form & strength, the route of administration,
 The identification numbers of all IND applications that
are referenced in the application,
 The drug products proposed indications for use
 Whether the submission is an original submission or
resubmission to an application.
 Whether the applicant proposes to market the drug
 product as a prescription or an OTC product.

13.  The applicant, or the applicant’s attorney, agent or
other authorised official shall sign the application
a)Index
 A comprehensive index by volume number & page
number to the summary, the technical sections, &
the supporting information.
b) Summary
 statement identifying the pharmacologic class of the
drug & a discussion of the scientific rationale for the
drug, its intended use, & the potential clinical
benefits of the drug.

14.  concluding discussion that represents benefit & risk
considerations related to the drug.
c)Technical sections
 chemistry, manufacturing, & controls section: Describing
the composition, manufacture, & specification of the drug
substance & the drug product.
 Non clinical pharmacology & toxicology section
 Human pharmacokinetics & bioavailability section
 Microbiology section (If the drug is anti-infective)

15.  A description of the biochemical basis of the drug action on
microbial physiology
 A description of the antimicrobial spectra of the drug to
demonstrate concentrations of the drug required for
effective use
 A description of any known mechanisms of resistance to
the
 A description of clinical microbiology laboratory methods
needed for effective use of drug

16. d) Clinical data section
 PHASE 1 : Used to describe the human pharmacology of
the drug and preferred route of administration.
 PHASE 2 : Involves dosing of a limited number of patients
for treatment or prevention of disease of interest. t
evaluates the effectiveness of the drug.
 PHASE 3 : Drug is assessed for its safety, effectiveness and
most desirable dosage for the disease to be treated and the
results are corrected and verified in large number of
patients.

17. e) Statistical section
 This section concerning the description & analysis of
each controlled clinical study, & the documentation &
supporting statistical analyses used in evaluating the
controlled clinical studies
 A copy concerning a summary of information about the
safety of the drug product, & the documentation &
supporting statistical analyses used in evaluating the
safety information.

18. f) Pediatric use section
 Includes the integrated summary of the information that is
relevant to the
 safety
 effectiveness
 benefits
 risks of the drug in pediatric populations for the claimed
indications.

19. g) Samples & labeling
Upon the request from FDA, the applicant shall submit
the samples
 The samples should be in sufficient quantity to permit FDA to
perform 3 times each test.
 Which is described in the application to determine whether the
drug substance & the drug product meet the specifications
given in the application
 The drug product proposed for marketing
 The drug substance used in the drug product from which
 the samples of the drug product were taken
 Reference standards & blanks
 Samples of the finished market package, if requested by FDA

20. h) Case report forms & tabulations:
Case report tabulations:
 Tabulations of the data from each adequate & well
controlled study phase 2 & phase 3 studies.
 Tabulations of the data from the earliest clinical
pharmacology studies phase 1 studies
 Tabulations of the safety data from other clinical studies.

21.  The applicant shall submit and accurate & complete
English translation of each part of the application that is
not in English.
i) Patent information
 If the FDA considers it acceptable it will then determine
application completeness.
 If complete, the FDA considers the application “filed ”
and begin the review process within 60 days.
 The purpose of NDA from FDA perspective is to ensure
that
 new drug meet the criteria to be safe and effective
 The FDA is required to review an application within 180
days of filing.

22. Review priority classification
 Under food drug and administration modernisation
act (FDAMA) depending on the anticipated
therapeutic or diagnostic value of submitted NDA, its
review might receive priority (p) or standard (s)
classification.
 Both original NDA ’s and effective supplements receive a
review priority classification
 During the NDA evaluation there is no guidelines or rules
that require open communication between FDA and
sponser.

23. Priority review
 The drug product if approved would be a
significant improvement compared with marketed
product in treatment, diagnosis or prevention of a
disease

24. Standard review
 All non priority application will be considered standard
application. i.e., application for drugs similar to those on
the market are considered standard

25. NDA Review

26. At the end of that, the FDA is required to respond with
an action letter.
Three action letters
 An approval letter
 An approvable letter
 An non approvable letter

27.  APPROVAL LETTER
It signifies that all substantive requirements for approval
are met with and that the sponsor company can begin
marketting drug as of the date on letter.
APPROVABLE LETTER
It signifies that application substantially compiles with
requirements but has minor deficiences that must be
addressed before an approval letter is sent. Within 10
days of reciept sponser must respond.

28.  NON APPROVABLE LETTER
It signifies that FDA has a major concern with
the application and will not approve the proposed
drug product for marketing as submitted

29. REFERENCE
 Modern pharmaceutics 4th edition Bankers
and Rohders
 Bankers medicinal chemistry and drug
discovery vol 2
 The text book of pharmaceutical
medicines, 5th edition by John P,Gruffin
and John O’ Grady