1. MANUFACTURING AUTHORIZATION AND
PRODUCT REGISTRATION
The federal food, drug and cosmetic act prohibit
the shipment of a new drug that is not covered
by an approved new drug application.

2.  A drug may be considered new because
of its composition, its use, its dosage or its
dosage form. It can readily be understood
that a drug that
 contains active ingredients a new chemical
entity or
 proportion of active ingredients or

3.  combination of active ingredients or
 A drug’s recommended new use or change
in recommended dosage, dosage form or
route of administration also can cause it to
be considered a new drug.

4. Investigational New Drug
 After its synthesis, a new chemical entity is
normally subjected to a screening process
which involves initial testing of the drug in
a small number of animals of different
species ( usually three) and
microbiological tests to detect any
beneficial effects of the chemical.

5.  If the initial screening proves the new chemical to be
worthy of further investigation, more animal tests are
conducted. Animal tests are designed to determine
 The relative toxicity including LD50, including specific
organ toxicity such as eyes, liver, and brain
 Animal tests are termed as preclinical investigations.

6.  Prior to the institution of clinical testing in
humans, the application is made by the sponsor to
the FDA. This is referred to as IND or investigational
new drug application.
 Information to furnished by the sponsor of the
investigation includes
 The name of the drug, chemical name and structure
of any new drug substance
 A complete list of components of the drug

7.  The quantitative composition of the drug
 The name and address of supplier of any new drug
substance if other than sponsor
 A statement of the methods, facilities and controls
used for the manufacture, processing and packaging
of the new drug
 A statement covering information derived from the
preclinical studies.

8.  Copies of the labels for the drugs and informational
material
 The name and curriculum vitae of all investigators

9.  An outline of the planned investigations of the new
drug in humans. These investigations are divided into
three phases.
 Phase 1: is the initial introduction of the drug into
humans for the purpose of determining toxicity,
metabolism, absorption, elimination, safe dose and
pharmacological action

10.  Phase 2: covers the initial trials for specific
therapeutic effect and is conducted on a limited
number of patients.
 Phase 3: of the clinical trial is intended to assess its
safety and effectiveness in one or more particular
indications.
 The regulations provide for a 30 day waiting
period, after which if the FDA has not responded
negatively, the clinical trials may commence.

11.  In the clinical study
 The investigator will maintain required records
of the study
 The investigator will inform patients that they
are in an investigational drug study and obtain
their consent for this involvement.

12. New drug application (NDA)
 The sponsor upon completion of clinical
work to demonstrate the safety and
effectiveness of the new drug for the use
or uses for which it is intended may then
submit a new drug application (NDA). this
application must include in addition to the
materials previously submitted to FDA in
the IND

13.  Detailed reports of the preclinical (animal)
studies
 Reports of all clinical studies
 Information on the composition,
manufacture of drug including controls
and facilities used in its manufacture

14. Samples of the drug and its labeling
 Once a new drug application is
approved, any significant change in the
manufacturing, control, packaging or any
change in the labeling must be covered
by a supplemental new drug application.
The requirement of an NDA for
prescription and over the counter drugs
is similar.

15.  Once approved reports of human clinical
experience are required to be submitted on
the following basis
 During the first three years following the date
of approval after every three monthly and
annually there after

16. Abbreviated New Drug Application (ANDA)
If the FDA agrees that a particular
pharmaceutical company (other than innovator
company that is the original inventor of new
drug), companies wishes to manufacture and
market the same product after or just before
the expiry of innovator’s patent( that is
exclusive right to manufacture and sale of new
drug), it can submit ANDA’s.

17.  The following information is necessary
to be furnished.
 Composition of the drug, stating the name
and amount of each ingredient whether
active or inactive in the dosage form

18.  Identify the place where the drug will be
manufactured, processed, packaged and
labeled and the name of the supplier of
the active ingredient (s).
 Includes certifications that the facilities
used are in conformity with current good
manufacturing practice

19.  Outline the methods used in, facilities,
controls used for the manufacture,
processing and packing of the drug.
 Bioequivalence data
 For ANDA full clinical studies are not
needed. FDA can grant approval for
Abbreviated New Drug to the interested
pharmaceutical companies after the
completion of 5 years of NDA.

20. THANK YOU