RA 9711

FOOD AND DRUG

ADMINISTRATION ACT OF 2009

DEFINITION OF TERMS:
FDA
FOOD
DRUG
DEVICE
-MEDICAL DEVICE
-RADIATION DEVICE
-HEALTH REL ATED DEVICE
COSMETICS
L ABEL
DIRECTOR- GENERAL
DISTRIBUTE
MANUFACTURER
VETERINARY DRUGS
ASS AY
AUTHORIZATION

BIOAVAI L ABI LITY

BIO EQU IVALEN CE
DISTR I BU TOR / IM PO RTE R /EXPO RTE R
DISTR I BU TOR / WH OLE S ALER
ESTABLISH MEN T
FO OD/DIE TARY SU PPL EMEN T
HEALTH PR O DU CTS
HO U SEHO LD/U R BAN HAZAR DOU S
SU BSTAN CE
IN-VITR O DIAGNO STIC R E AGE NTS
LICEN SING
MISBRAN DING
R EGISTRATION
TRADER
R ETAILER

HISTORICAL DEVELOPMENT

BEFORE R.A. 9711

 1961-62
Secretary Francisco Duque Sr. created a
subcommittee on Food and Drugs.
Undersecretary for Special Health Services: Dr. Rodolfo Caos
Members:
Dr. Trinidad Pesigan (Director of the Bureau of Research and
Laboratories)
Mr. Emilio Espinosa (Bureau of Health Services)
Ms. Amor Cita M. Pallera (Pharmacy Adviser; Office of the
Secretary of Health; Secretary and Liaison to Congress)

 June 22, 1963

Republic Act No. 3720 Food, Drug and Cosmetic
Act
1973
Narcotic Drugs Division, Bureau of Internal
Revenue, Department of Finance was transferred to
the Food and Drug Administration (FDA).

 December 2, 1982
Executive Order No. 851, the FDA was abolished
and created the Bureau of Food and Drugs (BFAD)
Mrs. Catalina C. Sanchez
1987
BFAD moved in Alabang, Muntinlupa City

 1987
Executive Order No. 175 Foods, Drugs and Devices
and Cosmetics Act
May 24, 1999
Executive Order No. 102 BFAD was expanded

August 18, 2009

Republic Act No. 9711
Renaming of BFAD to FDA
Approved by: Pres. Gloria Macapagal Arroyo
August 23, 2012
Dr. Kenneth Y. Hartigan-Go

Republic Act (RA) 3720 of the Republic of the Philippines

was amended with the passage of a new law, RA 9711 The Food and Drug Administration (FDA) Act of 2009.

FUNCTIONS, POWERS AND DUTIES OF

FOOD AND DRUG ADMINISTRATION
administer and supervise
collection of samples of food, drug and cosmetic.
analyze and inspect food, drug and cosmetic
establish analytical data and to recommend standards
of identity, purity, quality and fi ll of container.
issue certifi cate of compliance
levy, assess and collect fees for inspection, analysis
and testing of products and materials
certify batches of anti-biotic and anti-biotic
preparations

THE FOOD AND DRUG ADMINISTRATION

SHALL HAVE THE FOLLOWING
DIVISIONS:
Inspection and Licensing Division
Laboratory Division

 Section 6. The Food and Drug Administration shall

have a Food and Drug Administrator who shall be
appointed by the Secretary of Health subject to the
Civil Service rules and regulations.
Section 7. The Secretary of Health shall provide for
the additional personnel needed to carry out the
functions and duties of the Food and Drug
Administration.

POLITICAL PLAYERS

WHO ARE INVOLVED??

June 3, 2009, the
Senate Bill No. 2645
and House Bill No. 3293
were passed by Juan
Ponce Enrile and the
rest of the senators
together with Marilyn
B. Barua-Yap of the
House of
Representatives.
Senator Mar Roxas,
chair of the Senate
committee on trade
opposed this provision.

POPULATION AFFECTED

Manufactur
ers

Consume
rs

ALL
Are
affect
ed
Drugstor
es

Distributo
rs

R.A. 9711

DISCUSSION..

BFAD

FDA

STATE MUST

Enhance its regulatory

capacity
Strengthen its capability with
regards to:
Inspection
Licensing
Monitoring

R.A. 9711 IS AIMED, DIRECTED

AND DESIGNED TO:
Protect and promote the right to health of the
Filipino people
Help establish and maintain an eff ective health
product regulatory system and undertake appropriate
health human resource development and research,
responsive to the country's health needs and
problems.

OBJECTIVES:
To enhance and strengthen the
administrative and technical capacity of
the FDA in the regulation of establishments
and products under its jurisdiction.
To ensure the FDAs monitoring and
regulatory coverage over establishments
and products under its jurisdiction.
To provide coherence in the FDAs
regulatory system for establishments and
products under its jurisdiction.

S E C . 6 . S E C T I O N 5 O F R E P U B L I C AC T NO . 3 7 2 0 , A S
A M E N D E D , I S H E R E BY F U R T H E R A M E N D E D A N D N E W
S U B S E C T I O N S A R E A D D E D T O R E A D A S F O L L OWS :

SEC. 5. The FDA shall have the following centers and

offi ces:
Center for Drug Regulation and Research (to include
veterinary medicine, vaccines and biologicals)
Center for Food Regulation and Research
Center for Cosmetics Regulation and Research (to include
household hazardous/urban substances)
Center for Device Regulation, Radiation Health, and
Research

C E N T E R S S H A L L B E S O O R G A N I Z E D S U CH T H AT E ACH
W I L L H AV E , AT L E A S T, T H E F O L L OW I NG D I V I S I O N S :
Licensing and
Registration Division

responsible for evaluating health products and

establishments

Product Research
and Standards
Development
Division

conduct of research, development of standards and

regulations, compliance monitoring, and the
oversight and audit of related researches that would
ensure safety, quality, purity and efficacy of health
products

Laboratory Support
Division

conduct of research and appropriate tests and

calibration, analyses and trials of products including,
but not limited to, assays, and the conduct of
oversight and/or audit of centers conducting
bioavailability and bioequivalence tests and other
tests

The Administration
and Finance Office

following divisions: the Human Resource Development

Division; Property and Logistics Management Division;
Human Resource Management Division; Assets and
Financial Management Division; and the Information and
Communication Technology Management Division.

Policy and Planning

Office

training, advocacy and communications division and shall

monitor the performance of the centers for product
research and evaluation and standards development.

Field Regulatory

field offices, field or satellite laboratories and the

IMPLEMENTING BODIES

 Appointment of and Disciplinary Action Against All

Personnel. The appointment of, and disciplinary
action against, all offi cials, personnel, staff and
employees in the FDA shall be in accordance with the
FDA Act of 2009, these Rules and Regulations, and
relevant civil service laws, rules and regulations.
Director-General
Deputy Director- Generals
Administration and Finance
Field Regulatory Operation

Offi cials in Director

Assistant-Director Levels
Offi cials and Other Personnel and Employees Below the
Assistant
Director Level

PENALTIES
penalty of imprisonment ranging from one (1) year but
not more than ten (10) years or a fi ne of not less than
Fifty thousand pesos (P50,OOO.OO) but not more than
Five Hundred thousand pesos (P500,000.00), or both,
at the discretion of the court
The off ender is a manufacturer, importer or distributor
of any health product, the penalty of at least fi ve (5)
years imprisonment but not more than ten (IO) years
and a fi ne of at least Five hundred thousand pesos
(P500,OOO.OO) but not more than Five million pesos
(P5,000,000.00) shall be imposed
An additional of one percent (1%) of the economic value/cost
of the violative product or violation, or One thousand pesos
(Pl,OOO.OO), whichever is higher, shall be imposed for each
day of continuing violation

 Health products found in violation of the provisions of this

Act and other relevant laws, rules and regulations may be
seized and held in custody pending proceedings, without
hearing or court order, when the director-general has
reasonable cause to believe from facta found by him/her or an
authorized offi cer or employee of the FDA that such health
products may cause injury or prejudice to the consuming
public.

 Cancellation of any authorization which may have

been granted by the FDA, or suspension of the
validity thereof for such period of time as the
director-general may deem reasonable which shall not
exceed one (1) year
A fi ne of not less than Fifty thousand pesos
(P50,OOO.OO) but not more than Five hundred
thousand pesos (P500,OOO.OO). An additional fi ne of
not more than One thousand pesos (P1,OOO.OO) shall
be imposed for each day of continuing violation
Destruction and/or appropriate disposition of the
subject health product, and/or closure of the
establishment for any violation of this Act, as
determined by the director-general.

HEALTH IMPLEMENTATION