New Drug Approval Process .pptx

Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
IOP, Dhule
Shri Vile Parle Kelavani Mandal's Institute of Pharmacy, Dhule
Approved by PCI, AICTE, DTE
Affiliated to
Dr. Babasaheb Ambedkar Technological University
PRN NO : 2254482817012
(MPH103T) Pharmaceutical Regulatory Affairs
M Pharm 1st year Sem. I
Department of Pharmaceutics

IOP, Dhule
2
Drug
Discovery
Process
NDA
Introduction
USFDA
NDA
Classification
NDA
Format
Flowchart
POINTS TO BE DISCUSSED

IOP, Dhule

IOP, Dhule
7
DRUG
New Drug
Drug
Product

IOP, Dhule
8
UG DISCOVERY PROCESS

IOP, Dhule
9
A CLASSIFICATIONS
Introduction :
If clinical studies
confirm that a new
drug is relatively safe
and effective, and
will not pose
unreasonable risks to
patients, the
manufacturer files a
New Drug
Application (NDA),
the actual request to
manufacture and sell
the drug in the
United States.
NDA
• New Molecular Entity
NDA
• New Salt of Previously Approved Drug
NDA
• New Formulation of Previously Approved Drug
NDA
• New Combination of Two or More Drugs with New Indication
NDA
• Already Marketed Drug Product - No Previously Approved FDA

IOP, Dhule
10
DRUG APPROVAL IN UNITED STATES
History
10
1906
Food & Drug Act
Congress passed the original
Food and Drugs Act, which
require that drugs must meet
official standards of strength
and purity.
Kefauver Harris
Amm. Act
The Kefauver-Harris
Amendment Act was passed
which require that
manufacturers must prove
that drug is safe and effective
(for the claims made in
labelling).
.
1962
Pharmacopeia
The new era of USA drug
regulation was started with
the establishment of U.S.
Pharmacopoeia .
.
1820
Sulphanilamide
Tragedy
Due to Sulphanilamide
tragedy, the Federal Food,
Drug and Cosmetic Act (of
1938) was enacted and
added new provisions that
New drugs must be shown
safe before marketing.
.
1937

IOP, Dhule
11
FDA is a
public health
agency,
charged with
protecting
American
consumers by
enforcing the
Federal Food,
Drug, and
Cosmetic Act
and several
related public
health laws.
Why USFDA ?
•oldest consumer protection agency
•world’s most stringent standards
•Most demanding in the world.
FDA Approval Means :
•Data on the drug’s effects have been reviewed by
CDER
Mission
•Inspections and Legal Sanctions
•Scientific Expertise
•Product Safety
FDA Divisions
•CDER
•CBER
•CDRH
•CVM

IOP, Dhule
12
CDER’s
Mission
• Promote the Public Health by ensuring the availability of safe & Effective drugs
• Protect public health by promoting the safe use of marketed drugs.
• Protect public health by ensuring quality & integrity of marketed drug products
Office of
Pharmaceutical
Science
• Office of Generic Drugs
• Office of New Drug Chemistry
• Office of Pharmacology & Biopharmaceutics
• Office of Testing & Research
CENTER FOR DRUG EVALUATION & RESEARCH [ CDER ]

IOP, Dhule
13
 All New Drug
Applications must
contain the information
required in 21 CFR
314.50
 Two copies of the
application are needed:
an archival copy and a
review copy.
ERAL OVERVIEW OF NDA
Archival Copy
• Reference copy for FDA ( i.e. retained by FDA )
• Locate information not contained in review copy
• It must bound in Blue cover
Review Copy
 Divided in to five or six section containing technical and scientific
information separately bound
 Each section of the review copy should also contain a copy of Volume
1.1 with the following:
 A copy of the FDA cover letter
 A copy of the application form (FDA 356h)
 A copy of the index to the entire application
 A copy of the overall summary
 A copy of a letter of reference or authorization to
access NDAs, DMFs, etc.

IOP, Dhule
14
FOLDER COLORS & FORM
NUMBERS
Document Folder color Form number
Archival copy Light blue FD 2626
Chemistry, manufacturing, and
controls section (CMC)
Red FD 2626a
Nonclinical pharmacology and
toxicology section
Yellow FD 2626b
Human pharmacokinetics and
bioavailability section
Orange FD 2626c
Microbiology section White FD 2626d
Clinical data section Light brown FD 2626e
Statistical section Green FD 2626f
Field copy Maroon FD 2626h

IOP, Dhule
15
FOLDER
• Color of
Folder
• Ex. Blue For
Archival
copy
Paper Size &
Binding
• Page 8.5 – 11
inches
• Bound at left
side
• Accurately no
Pagination
• Page no of
both copy
should have
same
Volume size
• Not more than 2
inches thick
• Should have
name of
applicant, drug
and - NDA no
Packing
carton
• Box size 14 -12-
9.5 inches
ASSEMBLING OF THE
APPLICATION

IOP, Dhule
16
NDA APPLICATION SUMMARY
REQUIREMENT
• Annotated Package Insert
• Pharmacological Class, Scientific Rationale, Intended Use,
and Potential Clinical Benefits
• Foreign Marketing History
CMC
• Drug Substance
• Drug Product
• Nonclinical Pharmacology and Toxicology Summary
• Human Pharmacokinetics and Bioavailability Summary
• Microbiology Summary
• Clinical Data Summary and Results of Statistical Analysis
• Discussion of Risk / Benefit Relationship .

IOP, Dhule
 Chemistry, Manufacturing, and Control
 Nonclinical Pharmacology and Toxicology
 Pharmacology Trials
 Acute Toxicity Trials
Sub chronic/Chronic/Carcinogenicity
Trials
Special Toxicity Trials
Reproduction Trials
Mutagenicity Trials
Human Pharmacokinetics and
Bioavailability Section
Microbiology
Clinical Data Section
Outline of the Clinical Section
Other NDA Requirements
The Integrated Clinical/Statistical Report
Samples, Methods Validation, and
Labeling
Case Report Forms and Tabulations
17
TECHNICAL SECTION

IOP, Dhule
• A. Application Form List of INDs, NDAs, and DMFs referenced in the Application
• B. Patent Certification
• C. Application Summary
• D. Technical Data Sections :
(1) Chemistry, Manufacturing and Controls Section
(2) Nonclinical Pharmacology and Toxicology Section
(3) Human Pharmacokinetics and Bioavailability Section
(4) Microbiology Section
(5) Clinical Data Section
18
NDA FORMAT [FDA 356 # 3, 21 CFR
314 . 50(C)

IOP, Dhule
5. Clinical Data Section :
a. List of Investigators
b. Background/Overview of Clinical Investigations
c. Clinical Pharmacology Trials
d. Controlled Clinical Trials
e. Uncontrolled Clinical Trials
f. Other Trials and Information
g. Integrated Summary of Efficacy
h. Integrated Summary of Safety
i. Drug Abuse and Overdosage Information
j. Integrated Summary of Benefits and Risks k. GCP Statement
l. Transfer of Obligations
m. List of Audited Trials
19

IOP, Dhule
6. Statistical Data Section :
a. Controlled Clinical Trials
(i) Table of Controlled Clinical Trials
(ii) Table of Contents—Reports of Controlled Clinical Trials .
b. Integrated Summary of Efficacy
c. Integrated Summary of Safety
d. Risk Benefit Assessment
• E. Samples and Labeling
• F. Case Report Forms and Tabulations
a. Case Report Form Tabulations Table of Contents
b. Case Report Forms for Subjects Who Died or Discontinued
20

IOP, Dhule
21
REVIEW FLOWCHART

IOP, Dhule
22
A REVIEW PROCEDURE
Once FDA receives
an NDA, the review
team decides if it is
complete. If it is not
complete, the review
team can refuse to
file the NDA. If it is
complete, the review
team has 6 to 10
months to make a
decision on whether
to approve the drug.
Chemistry Clinical Statistics Biopharmaceutical Microbiology
FDA Advisory Committee
Arises Questions
Expert advice
Patient Representative
organize a meeting

IOP, Dhule
23
DRUG APPROVAL PROCESS IN
INDIA

IOP, Dhule
COMMON TECHNICAL
DOCUMENT

IOP, Dhule
• WWW.fda.gov
• WWW.ich.org/page /multidisciplinary-guidelines
• www.cdsco.gov.in
• The New Drug Application, Content and Format Richard A.Guarino Oxford
Pharmaceutical Resources, Inc., Totowa, New Jersey, U.S.A.
25
REFERENCES

IOP, Dhule
26

New Drug Approval Process .pptx

Recommended

Recommended

More Related Content

Similar to New Drug Approval Process .pptx

Similar to New Drug Approval Process .pptx (20)

Recently uploaded

Recently uploaded (20)

New Drug Approval Process .pptx