REGULATORY

GLOBAL SUBMISSION
OF IND,NDA,ANDA.
SUBMITTED BY- SRISHTY CHOUDHARY

M.PHARM 1ST YEAR
UNITED INSTITUTE OF PHARMACY
NAINI,ALLAHABAD
1
CONTENTS
 IND-Introduction
 IND chart
 Format and content of IND
 Types of IND’S
 NDA-Introduction
 Format and content of NDA
 General requirements for filing NDA
 NDA chart
 AND-Introduction
 Format and content of ANDA
 ANDA chart
 Conclusion
 Reference
2
INVESTIGATIONAL NEW
DRUG(IND)
 IND under 21 CFR 312.3 (B) as “A new drug or biological
drug that is used in clinical investigation”.
 The investigational new drug application is a request for

an exemption from the federal status that prohibits an
unapproved drug from being shipped in interstate
commerce.
 Once IND application is submitted the sponser must wait

for 30 days before initiating any clinical trail.
3
 The sponsor submits the application for conduct of human
clinical trials called IND application to FDA.
 Once IND application is submitted ,the sponser must wait for

30 days before initiating any clinical trial.
 Clinical trials in humans can begin only after IND is reviewed

by the FDA and a local institutional review board.
 IF the FDA accepts the IND request within 30 days of

submission ,clinical testing of new molecule on human may
begin by the investigator.
 If at anytime during clinical testing , the data furnished to FDA

indicate the IP to be toxic under criteria of FDA’s benefit ,FDA
can terminate clinical trial and its actions are not subject to
any judicial review.
4
IND CHART
5
FORMAT AND CONTENT OF IND
 Cover sheet (form FDA 1571).
 A table of contents.
 Introductory statement and general
investigational plan.
 Investigator’s brochure.
 Protocols.
 Chemistry,manufacturing and control
information.
 Previous human experience with IP.
 Additional information.
6
TYPES OF IND’S
[A]COMMERCIAL IND’S [B]NON-COMMERCIAL IND

 These are applications that  These IND’s are filed for
are submitted primarily by non –commercials
companies to obtain research.
marketing approval for a  Types of non- commercial
new product. IND:-
 Investigator’s IND.
 Emergency use IND.
 Treatment IND.
7
NEW DRUG APPLICATION
 The new drug application is the vehicle through which
the drug sponsors formally propose FDA or DCGI to
approve a new investigational drug for scale and
marketing after phase 3A pivot trials.
 Official definition of NEW DRUG according to sec 201 (p)

of federal drug ,food and cosmetics act:-
“Any drug the composition of which is such that it is not
recognised among experts qualified by scientific training
as safe and effective for use under prescribed
,recommended or suggested”.
8
FORMAT AND CONTENT OF NDA
 The application is required to be submitted in common
technical document format with the following different
format:-
 FDA form 356 h.
 User fee cover sheet (FDA form 3397).
 Cover letter.
 Summary.
 Chemistry ,manufacturing and control.
 Samples,method validation,package and labelling.
 Non clinical pharmacology and toxicology.
 Human pharmacokinetics and bioavailability.
 Microbiology.
 Statistical methods and analysis of clinical data.
 Safety update report.
9
 Statement regarding compliance to IRB and
informed consent requirement.
 Case report tabulations.
 Case report forms.
 Patent information and certification.
 Other information.
10
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.
 2-Non clinical pharmacology and toxicology.
 3-Human pharmacokinetics and bioavailability.
 4-Microbiology
 5-Clinical data
 6-Statistical
11
NDA CHART
12
 On receipt of NDA ,the CDER stamps with a receipt
data to enable FDA to forward action within 180 days
called ‘REVIEW CLOCK’ under REVIEW TIME FRAMES (21
CFR 314.100).
 The FDA assign 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.
 FDA inspects the manufacturing facilities for the drug ,it
may also inspect sample of clinical trial locations to
verify the accuracy of data submitted.
 Once all reviews are complete the divisional director
evaluates the reviews and make FDA’s decision.
13
ABBREVIATED NEW DRUG
APPLICATION (ANDA)
 Generic drug applications are referred to ANDA.
 Generic drug are termed ‘ABBREVIATED’ as they are not
required to include preclinical and clinical data to
establish safety and efficiency.
 They must scientifically demonstrate bioequivalence to
innovator drug.
 Use of bioequivalance as base for approving generic drug
products was established in 1984 also known as
‘WAXMAN-HATCH ACT ‘.
 It is because of this act that generic drugs are cheaper
without conducting costly and duplicate clinical trials.
14
FORMAT AND CONTENT OF ANDA
 3 copies of the abbreviated application are required to be submited;an
archival copy,a review copy and a field copy.
ARCHIVAL COPY-
• Application form
• Table of contents.
• Basis for ANDA submission.
• Condition of use.
• Active ingredients.
• Route of administration.
• Dosage form and strength.
• Bioequivalence and bioavailability .
• Labeling.
• Chemistry , manufacturing and control.
• Samples.
• Patent certificates.
• Financial certificates or disclosure statement.
• Other information.
15
ANDA CHART
16
SUMMARY
 The Drug approvals in the US, Europe & India are the most
demanding in the world. The primary purpose of the rules governing
medicinal products in US, Europe & India is to safeguard public
health. It is the role of public regulatory authorities to ensure that
pharmaceutical companies comply with regulations.
 Developing a new drug requires great amount of research work in

chemistry, manufacturing, controls, preclinical science and clinical
trials. Drug reviewers in regulatory agencies around the world bear
the responsibility of evaluating whether the research data support
the safety, effectiveness and quality control of a new drug product to
serve the public health.
17
REFERENCE:
 http://www.fda.gov/RegulatoryInformation/G
uidances/ucm129703.htm
 World Journal of Pharmaceutical Research ;
SJIF Impact factor 5.045;vol3, Issue 6,406-
411. Review Article ISSN 2277-7105.
 International Journal of Drug Regulatory
Affairs 2014 .
18
THANK YOU
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GLOBAL SUBMISSION

SUBMITTED BY- SRISHTY CHOUDHARY

 The investigational new drug application is a request for

 Once IND application is submitted the sponser must wait

 Once IND application is submitted ,the sponser must wait for

 Clinical trials in humans can begin only after IND is reviewed

 IF the FDA accepts the IND request within 30 days of

 If at anytime during clinical testing , the data furnished to FDA

[A]COMMERCIAL IND’S [B]NON-COMMERCIAL IND

 Official definition of NEW DRUG according to sec 201 (p)

 Developing a new drug requires great amount of research work in

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