Pharmaceutical Regulatory Affairs

1. GLOBAL SUBMISSION OF
ABBREVIATED NEW DRUG
APPLICATION (ANDA)
Under the guidance of
Dr. K. Sai Sruthi
M. Pharmacy, Ph. D.
K. Bhanu Sri Chandana
2020MPH40A023
M. PHARMACY
Dept. of Pharmaceutics

2. CONTENTS :
2
 Introduction
 Basic Generic Drug Requirements
 Hatch-Waxman Act
 Format and Contents of ANDA
 ANDA Review Process in different countries
 References

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 An abbreviated new drug application (ANDA) contains data which is submitted to
FDA for the review and potential approval of a generic drug product.
 Once ANDA is approved, the applicant may manufacture and market the generic
drug product to provide a safe, effective, lower cost alternative to the branded drug.
Abbreviated New Drug Application (ANDA)
 Generic drug applications are termed "abbreviated"
because they are generally not required to include
preclinical (animal) and clinical (human) data to establish
safety and effectiveness.

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Generic applicants must scientifically demonstrate that their product
performs in the same manner as the innovator drug.
 Demonstration of “bioequivalence”
gives the rate of absorption, or
bioavailability, of the generic drug,
which can then be compared to
that of the innovator drug

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Basic Generic Drug Requirements :

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Hatch-Waxman Act
[Drug Price Competition and Patent Term Restoration Act]
 This law encourages the manufacture of generic drugs by the pharmaceutical industry.
 This amendments established bioequivalence as the basis for approving generic copies
of drug products.
 Under the Hatch-Waxman Amendments, brand-name companies can gain patent term
extension for marketing exclusivity.
 The Act also gives generic companies safe harbor from patent infringement lawsuits
during the time when the generic company is preparing its ANDA.

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Format and Contents of ANDA
 Application Form
 Table of Contents
 Basis for ANDA submission
 Conditions of use
 Active Ingredients
 Routes of Administration
 Dosage Form and Strength
 Bioequivalence and Bioavailability
 Labelling
 CMC
 Samples
 Patent Certifications
 Disclosure Certifications
 Other Information

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ANDA Review Process in US
Applicant
ANDA
Acceptable
Review by OGD/CDER
Refuse to File Letter Issued
Bioequivalence Review Chemistry / Micro Review
Request for Plant Inspection Labelling Review
No
Yes

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Bioequivalence Review
Chemistry / Micro Review, Labelling Review,
Request for Plant Inspection
Yes
Bioequivalence Deficiency
Letter
Not Approvable Letter
Preapproval Inspection
ANDA Approval
No No
Approval deferred pending
satisfactory results
Yes No

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ANDA Review Process in INDIA
Innovator drug Approved in INDIA Approved Status by CDSCO
State Legislature Assembly
Manufacturing Licence
NOC Issued by SLA CDSCO Zonal / Sub
Zonal approval
ANDA Approval

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ANDA Review Process in Europe
Innovator drug Approved in Europe EMA Review of
application
Submission of application
to different State assemblies
Marketing authorization
ANDAApproval

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 www.fda.gov.in
 https://en.wikipedia.org/wiki/Drug_Price_Competition_and_Patent_Term_Restoratio
n_Act
 Generic drug regulatory approval process in the USA, Europe, and India G. Sai
Bhavani, M. P. Venkatesh*, T. M. Pramod Kumar
 https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/patent-
certifications-and-suitability-petitions
 https://www.slideshare.net/maruthishanskeli3/global-subbmission-of-ind-nda-anda
 https://www.slideshare.net/sagarsavale1/abbreviated-new-drug-application-anda
References :

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