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the

FDA
Gatmaitan Medrano
Food and Drug Administration
Formerly the Bureau of Food and Drugs
(BFAD)
Has several functions and powers acting
as a regulatory board for all food and
drugs marketed.
It was reorganized under the Republic Act
9711.
The Functions of the FDA
Can be classified into 4 major groups:
The collection and quality, efficacy and
SAFETY testing of health products samples.
Collection of data on adverse events and
possibly harmful products (largely
reactionary)
The recommendation of standards in the
storage, distribution and manufacture of
drugs.
The conduction of research on food and
drug products.
So

Data
Testing
Analysis

FDA

Standards Research
Specific provisions
o To administer the effective implementation
of R.A. 9711 and of the rules and regulations
issued pursuant to the same;
o To assume primary jurisdiction in the collection
of samples of health products;
o To analyze and inspect health products in
connection with the implementation of R.A. 9711;
o To establish analytical data to serve as basis
for the preparation of health products standards,
and to recommend standards of identity,
purity, safety, efficacy, quality and fill of
container;
Specific provisions
o To conductappropriate tests on all
applicable health products prior to the
issuance of appropriate authorizations to ensure
safety, efficacy, purity, and quality;
o To require all manufacturers, traders, distributors,
importers, exporters, wholesalers, retailers,
consumers, and non-consumer users of health
products to report to the FDA any incident
that reasonably indicates that said product has
caused or contributed to the death, serious
illness or serious injury to a consumer, a
patient, or any person;
Specific provisions
o To issue cease and desist orders motu propio
or upon verified complaint for health produts,
whether or not registered with the FDA Provided,
o After due process, to order the ban, recall,
and/or withdrawal of any health product
found to have caused the death, serious illness or
serious injury to a consumer or patient, or is found
to be imminently injurious, unsafe,
dangerous, or grossly deceptive, and to
require all concerned to implement the risk
management plan which is a requirement for the
issuance of the appropriate authorization;
Specific provisions
o To strengthen the post market surveillance
system in monitoring health products as
defined in R.A. 9711 and incidents of adverse
events involving such products;
o To develop and issue standards and
appropriate authorizations that would cover
establishments, facilities and health products;
o To conduct, supervise, monitor and audit
research studies on health and safety issues
of health products undertaken by entities duly
approved by the FDA;
Specific provisions
o To prescribe standards, guidelines, and
regulations with respect to information,
advertisements and other marketing instruments
and promotion, sponsorship, and other
marketing activities about the health products as
covered in R.A. 9711;
o To maintain bonded warehouses and/or
establish the same, whenever necessary or
appropriate, as determined by the director-
general for confiscated goods in strategic areas
of the country especially at major ports of entry;
and
o To exercise such other powers and perform such
other functions that may be necessary to carry
out its duties and responsibilities under R.A.9711.
A food/dietary supplement
Is a processed food product intended
to supplement the diet

vitamin mineral
Food
supplement

Amino Herb/ other


acid botanicals
A food/dietary supplement

conforms to the latest Philippine


recommended energy and nutrient
intakes or internationally agreed
minimum daily requirements.
Herbal medicines are

finished, labeled, medicinal products


that contain as active ingredient/s
aerial or underground part/s of plant
or other materials or combination
thereof, whether in the crude state or
as plant preparations.
Herbal medicines are

Juices Gums
Plant
matter
Isolated
Oils plant
constituents
Herbal medicines are
recognized in the Philippine National
Formulary;
intended for use in the treatment or cure,
mitigation, of disease symptoms, injury or
bodily defect for use in man;
other than food, intended to affect the
structure of any function of the body of
man;
put into finishes, ready to use form by
means of formulation, dosage or dosage
directions;
How are locally manufactured
drugs approved?

Application Safety tests

Paying of
Quality
Registration
Control
Fees
Step 1: Application (A.O. 42)
The application contains all the
following:
Full list and amount of all ingredients used
Technical specification of all the ingredients
used as component.
Description of the finished drug product.
Labels, labelling materials, package insert,
brochures and other advertising materials
Sufficient sample for laboratory analysis.
Step 2: Safety Tests
Oral LD50 in Rats
Pharmacologic studies
in vitro-depending on tissue uses; on dogs,
cats and turtles
in vivo-on-dogs and cats.
Mutagenicity studies
in vitro
in vivo
Date on safety and efficacy
Dosage formulation
Step 3: Quality Control
Test for the presence of synthetic drugs
Test for the presence of heavy metals
Test for alcohol content (<10%)
Analysis for Impurities
Characteristics of the drug in tablet form,
suspension form, ointment and
suppository preparations.
Step 4: Payment
Drug preparation containing only one
active ingredient shall be charged a fee
of fifty pesos (P50.00)
Those containing more than one active
ingredients shall be charged a fee of one
hundred pesos (P100.00)
Administrative Acts of the FDA
EO 51 Milk Code
IRR of EO 51 - Revised Implementing
Rules & Regulations of Milk Code
EO 302 Philippine Pharmacopoeia
RA 9257 - Expanded Senior Citizens
Act of 2003
RA 9211 Tobacco regulation Act
of 2003
IRR of RA 9211 Inter-Agency
Committee - Tobacco
Rationale of Renaming BFAD
RA No. 9711
The Bureau of Food and Drugs (BFAD) was
renamed as the Food and Drug
Administration (FDA) to strengthen and
rationalize its regulatory capacity thru
The establishment of adequate testing
laboratories and field offices,
Upgrading its equipment
Augmenting its human resource
complement
And by giving authority to retain its income