Definitions according to Regulatory Authorities/Agencies

1. DEFINITIONS
AROOJ ABID
PHARM.D, CRCP, R.Ph

2. ACTIVE PHARMACEUTICAL
INGREDIENT

3. U.S. FDA
Any substance or mixture of substances
intended to be used in the manufacture of a
drug (medicinal) product and that, when used in
the production of a drug, becomes an active
ingredient of the drug product. Such substances
are intended to furnish pharmacological activity
or other direct effect in the diagnosis, cure,
mitigation, treatment, or prevention of disease or
to affect the structure or function of the body.

4. • Reference:
Manufacturing, Processing, or Holding Active
Pharmaceutical Ingredients FDA Guidance
• Link:
http://www.registrarcorp.com/fda-guidance/fda-
definitions/drugs.jsp

5. WHO
Any substance or combination of substances used
in a finished pharmaceutical product (FPP),
intended to furnish pharmacological activity or to
otherwise have direct effect in the diagnosis, cure,
mitigation, treatment or prevention of disease, or to
have direct effect in restoring, correcting or
modifying physiological functions in human beings.

6. Reference:
Link:
http://www.who.int/medicines/areas/quality_safety
/quality_assurance/DefinitionAPI-QAS11-
426Rev1-08082011.pdf

7. DRUG LAWS
Active pharmaceutical ingredient means a
substance or compound that is intended to be
used in the manufacture of a pharmaceutical
product as a pharmacologically active compound
(ingredient).
Reference: Page # 87, Manual of drug laws of
Pakistan

8. HEALTH CANADA
Active ingredients (AI) are substances or mixture
of substances that, when used as a raw material in
the fabrication of a drug in dosage form, provide
the intended effect. The AI contained in most
pharmaceuticals are chemical in origin and are
often referred to as active pharmaceutical
ingredients (API).

9. Reference:
Link:
http://www.gazette.gc.ca/rp-pr/p2/2013/2013-05
08/html/sor-dors74-eng.html

10. EMA
Any component that is intended to furnish
pharmacological activity or other direct effect in
the diagnosis, cure, mitigation, treatment, or
prevention of disease, or to effect the structure
or any function of the body of man or other
animals.
Reference:
Link:
http://gabionline.net/Biosimilars/General/EMA-
definitions-of-generics-and-biosimilars

11. GENERIC

12. DRUG LAWS
Generic name means the non-proprietary,
scientific or official name of a drug as approved
by the Federal Government.
Reference: Page# 6, Manual of drug laws of
Pakistan

13. U.S. FDA #1
A generic drug is the same as a brand name
drug in dosage, safety, strength, how it is taken,
quality, performance, and intended use.

14. Before approving a generic drug product, FDA
requires many rigorous tests and procedures to
assure that the generic drug can be substituted
for the brand name drug. The FDA bases
evaluations of substitutability, or "therapeutic
equivalence," of generic drugs on scientific
evaluations. By law, a generic drug product must
contain the identical amounts of the same active
ingredient(s) as the brand name product. Drug
products evaluated as "therapeutically
equivalent" can be expected to have equal effect
and no difference when substituted for the brand
name product.

15. Reference:
Link:
http://www.fda.gov/Drugs/InformationOnDrugs/uc
m079436.htm

16. U.S. FDA #2
A generic drug is identical--or bioequivalent--to a
brand name drug in dosage form, safety,
strength, route of administration, quality,
performance characteristics and intended use.
Reference:
Link:http://www.fda.gov/Drugs/ResourcesForYou/
Consumers/BuyingUsingMedicineSafely/Unders
tandingGenericDrugs/ucm144456.htm

17. EMA
A generic medicine is a medicine that is
developed to be the same as a medicine that
has already been authorised, called the
reference medicine.
Reference:
Link:http://www.ema.europa.eu/ema/index.jsp?cur
l=pages/special_topics/document_listing/docum
ent_listing_000335.jsp&mid=WC0b01ac058051
4d5c

18. GENERIC MEDICINAL PRODUCT

19. A medicinal product which has the same
qualitative and quantitative composition in active
substances and the same pharmaceutical form
as the reference medicinal product, and whose
bioequivalence with the reference medicinal
product has been demonstrated by appropriate
bioavailability studies.
Reference: (Reg. 726/2004, Art 10, 2b)
Link:http://gabionline.net/Biosimilars/General/EMA
-definitions-of-generics-and-biosimilars

20. TGA
The generic medicine must be bioequivalent to
the Australian reference product.
Reference:
Link:https://www.tga.gov.au/book/156-choice-
reference-product-bioequivalence-generic-
medicines

21. SEMI BASIC

22. DRUG LAWS
Semi basic manufacture means manufacture from
an intermediate substance of a drug to be used
as a starting material for the formulation of a
finished drug or to be used for repacking.
Reference: Page# 92, Manual of drug laws of
Pakistan

23. U.S. FDA
Semi-synthetic Drug Substances
A semi-synthetic drug substance is one in which
the structural constituents have been introduced
by a combination of chemical synthesis and
elements of biological origin (e.g., obtained from
fermentation or by extraction from botanical
material).
• Reference:
• Link:
http://www.fda.gov/downloads/drugs/guidances/
ucm261078.pdf

24. NEW CHEMICAL ENTITY/ NEW
DRUG

25. DRUG LAWS
New drug means a drug that has not been
commonly sold or distributed to the public in
Pakistan and is introduced for the first time.
Reference: Page# 90, Manual of drug laws of
Pakistan

26. U.S. FDA #1
A New Molecular Entity is an active ingredient that
has never before been marketed in the United
States in any form.
Reference:
Link:
http://www.fda.gov/Drugs/InformationOnDrugs/u
cm079436.htm

27. U.S. FDA #2
New chemical entity means a drug that contains
no active moiety that has been approved by
FDA in any other application submitted under
section 505(b) of the act.
Reference:
Link:https://www.accessdata.fda.gov/scripts/cdrh/c
fdocs/cfCFR/CFRSearch.cfm?fr=314.108

28. ME TOO DRUGS/ FOLLOW ONS

29. U.S. FDA
A compound that is structurally very similar to
already known drugs, with only minor
pharmacological differences.
Reference:
Link:http://www.genomicglossaries.com/content/dr
ug_approvals.asp