Mandate

As a regulatory agency under the Department of Health, the Food and Drug Administration, created under Republic Act
No. 3720, series of 1963, as amended by Executive Order 175, series of 1987, otherwise known as the “Food, Drugs and
Devices, and Cosmetics Act”, and subsequently Republic Act No. 9711 otherwise known as “The Food and Drug
Administration Act of 2009”, is mandated to ensure the safety, efficacy or quality of health products as defined by RA
No. 97111, which include means food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents,
radiation-emitting devices or equipment, and household/urban hazardous substances, including pesticides and toys, or
consumer products that may have an effect on health which require regulations as determined by the FDA.

Among others, the FDA is also mandated to enforce the provisions of the following laws:

 RA 9502, or The Universally Accessible Cheaper and Quality Medicine Act of 2008,

 RA 6675, or The Generics Act Of 1988,

 RA 5921, or The Pharmacy Law,

 RA 9211, or The Tobacco Regulation Act of 2003

 RA 7394, or The Consumer Act of the Philippines

 RA 7581/10623, or The Price Act

 RA 10611, or The Food Safety Act of 2013

 RA 8172, or The ASIN Law,

 RA 8203, or The Special Law on Counterfeit Drug

 RA 8976, or The Food Fortification Law

 RA 9165, or The Comprehensive Dangerous Drugs Act

 RA 9257, or The Expanded Senior Citizens Act of 2003

 PD No. 881, or The Household Hazardous Act

 EO No. 51, or The Milk Code of the Philippines

 RA 10354, or The Responsible Parenthood and Reproductive Health Bill of 2012

 PD 856, or The Code of Sanitation of the Philippines

Functions
In order to protect and promote the right to health of the Filipino people and to establish and maintain an effective
health products regulatory system responsive to the country’s health needs and problems, the FDA shall perform the
following functions as provided by existing laws:

 To establish safety or efficacy standards and quality measures for foods, drugs and devices and cosmetics and
other health product;
 To undertake appropriate health manpower development and research, responsive to the country's health
needs and problems;
 To assume primary jurisdiction in the collection of samples of health products;
 To analyze and inspect health products;
  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;
 To issue certificates of compliance with technical requirements to serve as basis for the issuance of appropriate
authorization and spot-check for compliance with regulations regarding operation of manufacturers, importers,
exporters, distributors, wholesalers, drug outlets, and other establishments and facilities of health products, as
determined by the FDA
 To conduct appropriate tests on all applicable health products prior to the issuance of appropriate
authorizations to ensure safety, efficacy, purity, and quality;
 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;
 To issue cease and desist orders motu propio or upon verified complaint for health produts, whether or not
registered with the FDA Provided, That for registered health products, the cease and desist order is valid for
thirty (30) days and may be extended for sixty (60) days only after due process has been observed;
 To order the ban, recall, and/or withdrawal of any health product, after due process, 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;
 To strengthen the post market surveillance system in monitoring health products as defined in this Act and
incidents of adverse events involving such products;
 To develop and issue standards and appropriate authorizations that would cover establishments, facilities and
health products;
 To conduct, supervise, monitor and audit research studies on health and safety issues of health products
undertaken by entities duly approved by the FDA;
 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
 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
 To exercise such other powers and perform such other functions as may be necessary to carry out its duties and
responsibilities.

FUNCTIONAL OBJECTIVES
FUNCTIONAL OBJECTIVES

1. Financial Perspective
a. Improve cost structure
b. Increase asset utilization
c. Enhance Customer value
d. Expand revenue opportunities

2. Customer Perspective (Customer Excellence)

a. Production of service attributes
b. Relation and Image development

3. Internal Perspective (Process Excellence)

a. Operation management processes
b. Public service management processes
c. Innovative Processes

4. Learning and Growth Perspective (Organizational Efficiency)

a. Human capital (Skills, training, knowledge)
b. Information capital (System, databases, networks)
c. Orgazinational capital (Skills/training, knowlege, teamwork)

FDA Core Values

SPIEL

SPIRITUALITY - Pagiging Maka-Diyos refers to our belief, love and faith for a Higher Being

SOUNDNESS - Pagiging Matuwid sa Isip at sa Gawa refers to our Good judgment in all aspect of Work

PATRIOTISM - Pagiging Makabayan refers to our love for our country and fellowmen

INTEGRITY - Pagiging Matapat refers to our consistent adherence to strong and ethical principles, wether alone or in
public

INNOVATION - Pagiging Malikhain at Maparaan refers to our forthright character to propose new things to improve our
products and services within the bounce of law and norms

EXCELLENCE - Pagiging Mahusay refers to our Highest degree of professionalism and superior work standard in
discharging one's duty

EXCECUTION - Pagpapatupas refers to our strong determination to put plans into action and concrete output

LEADERSHIP - Mahusay na Pamumuno refers to the management thinking that all employees in all levels of public
service who, at their best, care and do something about the challenges faced by the FDA

FDA QUALITY POLICY

FDA QUALITY POLICY

Our highest commitment is to ensure the

safety, efficacy and quality of health products.

Towards this end,

we commit to maintain and establish science-based policies
based on national and international standards
as the basis for regulatory policies,
to continually improve and maintain
our competencies in relation
to our regulatory function,
and to deliver quality public
service with integrity and efficiency

FDA STRATEGIC OBJECTIVES

FDA STRATEGIC OBJECTIVES

RESTRUCTURING THE AGENCY'S FOUNDATION

(Year 2017-2019)

Establish an effective management information and operationg system

Reform the organizational structire and development resource
Strengthen enforment of FDA-Implemented laws, rules and regulations
Upgrade and improve facilities and infrastructure
Develop a sound and balance regulatory framework
Foster public confidence through effective communication

NEW STRATEGIES TO ACCELERATE GROWTH

(Year 2020-2021)

Cooperate and collaborate with other government agencies

Build a global presence and international accreditation
Increase digital enforcement activities
Develop mutual cooperation efforts and reciprocity with reputable National Regulatory Authorities and international
activities
Increase FDA Academy Service Portfolio