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REGULATORY AFFAIRS
NON CLINICAL DRUG DEVELOPMENT:
GLOBAL SUBMISSION OF ANDA
Presented by
ABDUL NAIM
M.Pharm Pharmaceutics Department
Nargund college of pharmacy
ABBREVIATED NEW DRUG APPLICATION (ANDA):
 Generic drug applications are referred to Abbreviated
New Drug Application.
 Pharmaceutical companies must admit ANDAs and
receive FDAs approval before marketing new generic
drugs according to 21CFR 314.105(d).
 Once ANDA is approved, an applicant can
manufacture and market generic drug to provide safe,
effective and low cost alternative of innovator drug
product to the public.
 Generic drugs are termed ‘abbreviated’ as they are
not required to include preclinical and clinical data to
establish safety and efficacy. They must scientifically
demonstrate Bioequivalence to Innovator (brand
name) drug.
 A generic drug is comparable to Innovator drug I
dosage form, strength, route of administration,
quality, performance and intended use.
 One of the ways to demonstrate bioequivalence is to
measure the time taken by generic drug to reach
bloodstream in 24-36 healthy volunteers. The time
and amount of active ingredients in the bloodstream
should be comparable to those of Innovator drug.
 Use of bioequivalence as base for approving generic
drug products was established in 1984, also known as
HATCH-WAXMAN ACT. It is because of this act that
generic drugs are cheaper without conducting costly
and duplicative clinical trials.
Code of Federal Regulations:-
The following regulations apply to ANDA process;
 21 CFR 314:- Applications for FDA approval to market a
New Drug or Antibiotic Drug.
 21 CFR 320:- Bioavailability and Bioequivalence
requirement.
 21 CFR 310:- New Drugs.
 Office of Generic Drug (OGD) strongly encourages
submission of bioequivalence, chemistry and labeling
portions of the application in electronic format.
Format and Content of ANDA:-
 3 copies of the Abbreviated application are required
to be submitted; an archival copy, a review copy and a
field copy. An Archival copy shall contain the
following;
• Application form
• Table of contents
• Basis for ANDA submission
• Conditions of use
• Active ingredients
• Route of administration
• Dosage form and strength
• Bioequivalence and Bioavailability
• Labeling
• Chemistry, Manufacturing and Controls
• Samples
• Patent certification
• Financial certification or disclosure statement
• Other information
Under section 314.94 (a)(12), the patent certification includes
one of the following;
I. Para I Certification:- That the patent information has not
been submitted to FDA.
II. Para II Certification:- That the patent are expired.
III. Para III Certification:- That the patent will expire (on date
of marketing.
IV. Para IV Certification:- That the patent is invalid.
Submission of ANDA:-
ANDA requires submission of;
 Detailed description of components.
 Manufacturing, controls, packaging, data to assure
bioequivalence and bioavailability and labeling.
Labeling should be prepared in accordance with DESI
(Drug efficacy study implementation.
EXCLUSIVITY:-
 Exclusivity is a statutory provision designed to
promote a balance between an Innovator and
Generic drug competitor. As long as a drug patent
lasts, a reference listed drug company enjoys a
period of market exclusivity. Expiration of patent
removes the market exclusivity of the patent holder.
 term of exclusivity;
• Orphan drugs………….7 years
• New chemical entity…….5 years
• Pediatric exclusivity………6 months
• Patent challenge……….180 days
Hatch-waxman amendments and 180 days
exclusivity:-
 Before Hatch-waxman amendment, generic
manufacturer could file ANDA only after innovator’s
patent expiry or cancellation.
 under section 505 (j)(5)(B) of Hatch waxman
amendment it permits preparation and filing of ANDA
before patent expiration, so that the effective approval
date of generic drug would be on expiration date of the
patent of innovator original drug.
 The Act also establishes another procedure in which
the generic company can challenge patent of the
Innovator.
 For generic companies, the amendment provide an
inventive 180-day exclusivity period in which no other
ANDA for that the drug can be approved.
 This 180-day period is to encourage generic
companies to challenge validity of ORANGE BOOK
listed patents or to design around these patent to
bring more quickly a generic drug to market.
 For Innovator company, filing of an ANDA is an act of
patent infringement. So, if innovator company brings
suit within 45 days, the approval of generic
company’s ANDA is delayed for upto 30 months.
global submission of ANDA .pptx

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global submission of ANDA .pptx

  • 1. REGULATORY AFFAIRS NON CLINICAL DRUG DEVELOPMENT: GLOBAL SUBMISSION OF ANDA Presented by ABDUL NAIM M.Pharm Pharmaceutics Department Nargund college of pharmacy
  • 2. ABBREVIATED NEW DRUG APPLICATION (ANDA):  Generic drug applications are referred to Abbreviated New Drug Application.  Pharmaceutical companies must admit ANDAs and receive FDAs approval before marketing new generic drugs according to 21CFR 314.105(d).  Once ANDA is approved, an applicant can manufacture and market generic drug to provide safe, effective and low cost alternative of innovator drug product to the public.  Generic drugs are termed ‘abbreviated’ as they are not required to include preclinical and clinical data to establish safety and efficacy. They must scientifically demonstrate Bioequivalence to Innovator (brand name) drug.
  • 3.  A generic drug is comparable to Innovator drug I dosage form, strength, route of administration, quality, performance and intended use.  One of the ways to demonstrate bioequivalence is to measure the time taken by generic drug to reach bloodstream in 24-36 healthy volunteers. The time and amount of active ingredients in the bloodstream should be comparable to those of Innovator drug.  Use of bioequivalence as base for approving generic drug products was established in 1984, also known as HATCH-WAXMAN ACT. It is because of this act that generic drugs are cheaper without conducting costly and duplicative clinical trials.
  • 4. Code of Federal Regulations:- The following regulations apply to ANDA process;  21 CFR 314:- Applications for FDA approval to market a New Drug or Antibiotic Drug.  21 CFR 320:- Bioavailability and Bioequivalence requirement.  21 CFR 310:- New Drugs.  Office of Generic Drug (OGD) strongly encourages submission of bioequivalence, chemistry and labeling portions of the application in electronic format.
  • 5. Format and Content of ANDA:-  3 copies of the Abbreviated application are required to be submitted; an archival copy, a review copy and a field copy. An Archival copy shall contain the following; • Application form • Table of contents • Basis for ANDA submission • Conditions of use • Active ingredients • Route of administration • Dosage form and strength • Bioequivalence and Bioavailability
  • 6. • Labeling • Chemistry, Manufacturing and Controls • Samples • Patent certification • Financial certification or disclosure statement • Other information Under section 314.94 (a)(12), the patent certification includes one of the following; I. Para I Certification:- That the patent information has not been submitted to FDA. II. Para II Certification:- That the patent are expired. III. Para III Certification:- That the patent will expire (on date of marketing. IV. Para IV Certification:- That the patent is invalid.
  • 7.
  • 8. Submission of ANDA:- ANDA requires submission of;  Detailed description of components.  Manufacturing, controls, packaging, data to assure bioequivalence and bioavailability and labeling. Labeling should be prepared in accordance with DESI (Drug efficacy study implementation.
  • 9. EXCLUSIVITY:-  Exclusivity is a statutory provision designed to promote a balance between an Innovator and Generic drug competitor. As long as a drug patent lasts, a reference listed drug company enjoys a period of market exclusivity. Expiration of patent removes the market exclusivity of the patent holder.  term of exclusivity; • Orphan drugs………….7 years • New chemical entity…….5 years • Pediatric exclusivity………6 months • Patent challenge……….180 days
  • 10. Hatch-waxman amendments and 180 days exclusivity:-  Before Hatch-waxman amendment, generic manufacturer could file ANDA only after innovator’s patent expiry or cancellation.  under section 505 (j)(5)(B) of Hatch waxman amendment it permits preparation and filing of ANDA before patent expiration, so that the effective approval date of generic drug would be on expiration date of the patent of innovator original drug.  The Act also establishes another procedure in which the generic company can challenge patent of the Innovator.
  • 11.  For generic companies, the amendment provide an inventive 180-day exclusivity period in which no other ANDA for that the drug can be approved.  This 180-day period is to encourage generic companies to challenge validity of ORANGE BOOK listed patents or to design around these patent to bring more quickly a generic drug to market.  For Innovator company, filing of an ANDA is an act of patent infringement. So, if innovator company brings suit within 45 days, the approval of generic company’s ANDA is delayed for upto 30 months.