Republic of the Philippines 
HOUSE OF REPRESENTATIVES 
Quezon City 
19TH CONGRESS 
First Regular Session 
HOUSE BILL NO. ___ 
Introduced by Representative Michael L. Romero 
 EXPLANATORY NOTE 
The Food and Drug Administration (FDA) of the Philippines, formerly 
the Bureau of Food and Drugs BFAD , is a health regulatory agency under 
the Department of Health created on 1963 by Republic Act No. 3720, 
amended on 1987 by Executive Order 175 otherwise known as the “Food, Drugs 
and Devices, and Cosmetics Act”, and subsequently reorganized by Republic 
Act No. 9711 otherwise known as “The Food and Drug Administration Act of 
2009”. The agency is responsible for licensing, monitoring, and regulation 
of cosmetics, drugs, foods, household 
hazardous 
products, medical 
devices[2] and electromagnetic 
radiation emitting 
devices, pesticides, tobacco 
and related products, and vaccines for safety, efficacy, and quality in 
the Republic of the Philippines. 
The Philippine FDA is led by the Director General appointed by the President of 
the Philippines and two deputies for Internal Management and Field Regulatory 
Operations. 
The FDA has its central office in Alabang, Muntinlupa. The agency has 4 centers 
located at its central office, and 5 clusters of field regulatory operations and 4 
laboratories located throughout the archipelago. The agency also grants 
accreditation to private sector laboratories for testing of COVID-19 
. 
This House Bill seeks to provide Modernization Funding to the Food and Drug 
Administration (FDA), to guarantee the safety, quality, purity, efficacy of 
products in order to protect and promote the right to health of the general public. 
October 26, 2022
10:16 am
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Thus, the early passage of this bill is earnestly requested.  
MICHAEL L. ROMERO  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Republic of the Philippines 
HOUSE OF REPRESENTATIVES 
Quezon City 
19TH CONGRESS 
First Regular Session 
HOUSE BILL NO. ___ 
Introduced by Representative Michael L. Romero 
AN ACT 
PROVIDING FOR MODERNIZATION FUNDINGFOR THE FOOD AND 
DRUG ADMINISTRATION (FDA), INCREASING AND 
REORGANIZING ITS ADMINISTRATION, TO GUARANTEE THE 
SAFETY, QUALITY, PURITY, EFFICACY OF PRODUCTS IN ORDER 
TO PROTECT AND PROMOTE THE RIGHT TO HEALTH OF THE 
GENERAL PUBLIC AND FOR OTHER PURPOSES 
Be it enacted by the Senate and House of Representatives of the Philippines in 
Congress assembled: 
SECTION 1. 
DECLARATION OF POLICY – It shall hereby be a 
declared policy of the State that the FDA 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 which include food, drugs, 
cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents, radiation-
emitting devices or equipment, and household/urban hazardous substances, 
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including pesticides and toys, or consumer products that may have an effect on 
health which require regulations as determined by the FDA. 
The state shall continually improve the effectiveness of our Quality 
Management System towards equitable development for improved quality of life 
for all. 
The state shall formulate policies for the efficient and effective administration 
and management of all manpower, skills and competencies to ensure 
compliance. 
SECTION 
2. 
MODERNIZATION FUNDING. – The amount of Five 
Hundred Million Pesos (Php 500,000,000.00) for the operation and 
administration of the Food and Drug Administration (FDA) shall be chargeable 
against funds for the purpose and other sources recommended by the 
Department of Budget and Management (DBM). Thereafter, appropriations for 
the Food and Drug Administration (FDA) shall be included in the budget 
proposals under the Department of Health (DOH). 
 
The Department of Budget and Management (DBM) shall rationalize the existing 
organizational structure and staffing pattern of the Food and Drug 
Administration (FDA) in accordance with the provisions of this Act and relevant 
compensation and position classification laws, rules and regulations. 
Thereafter, the amount needed for the continued implementation of the 
modernization program, shall be included in the annual General Appropriations 
Act (GAA). 
SECTION 
3. 
FOOD 
AND 
DRUG 
ADMINISTRATION (FDA) 
MODERNIZATION FUND – There is hereby created the (FDA) Modernization 
Fund to be used exclusively for the (FDA) Modernization Program. 


The (FDA) Modernization Fund shall be administered by the Secretary of the DOH 
in accordance with existing government budgeting, accounting and auditing 
rules and regulations. 
SECTION 
4. 
PROGRESS REPORT – The Secretary of DOH shall 
prepare an annual report on the status of the implementation of the (FDA) 
Modernization Programs which shall be submitted, to the Office of the President 
and to the Chairpersons of the Committee on Health of the Senate and the House 
of Representatives. 
SECTION 
5. 
PERIOD OF IMPLEMENTATION – The modernization 
program under this Act shall be implemented for an initial period of two (2) 
years:  
Provided, that payments for multi-year contract obligations incurred 
under this Act may extend beyond this period:  
Provided, further, That the Food and Drug Administration (FDA) shall 
continue to develop, modernize and constantly update its operational capabilities 
to keep pace with best global practices. 
SECTION 
6. 
POWERS AND FUNCTIONS. – The Food and Drug 
Administration (FDA) shall continue to exercise and uphold the following 
powers and functions; but not limited to: 
To prevent international spread of diseases of global impact with minimum 
interference to international travel and trade through: 
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: 


a) To establish safety or efficacy standards and quality 
measures for foods, drugs and devices and cosmetics and 
other health product; 
b) To undertake appropriate health manpower development 
and research, responsive to the country’s health needs and 
problems; 
c) To assume primary jurisdiction in the collection of samples 
of health products; 
d) To analyze and inspect health products; 
e) 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; 
f) 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; 
g) To conduct appropriate tests on all applicable health 
products 
prior 
to 
the 
issuance 
of 
appropriate 
authorizations to ensure safety, efficacy, purity, and 
quality; 
h) 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; 


i) To issue cease and desist orders motu propio or upon 
verified complaint for health products, 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; 
j) 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; 
k) To strengthen the post market surveillance system in 
monitoring health products as defined in this Act and 
incidents of adverse events involving such products; 
l) To 
develop 
and 
issue 
standards 
and 
appropriate 
authorizations that would cover establishments, facilities 
and health products; 
m) To conduct, supervise, monitor and audit research studies 
on health and safety issues of health products undertaken 
by entities duly approved by the FDA; 
n) 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; 
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 


p) To exercise such other powers and perform such other 
functions as may be necessary to carry out its duties and 
responsibilities 
 
SECTION 
7. 
INCREASE OF PERSONNEL. – The FDA shall maintain 
the sufficient staffing pattern. Hence, it is authorized to increase its manpower 
to meet such required and may continue to increase personnel per percentage 
rate increase of committed mandates annually or as the need arises. 
SECTION 
8. 
TRANSITORY 
PROVISION – 
Existing 
industries, 
businesses and offices affected by the implementation of this Act shall be given 
six (6) months transitory period from the effectivity of the IRR or such other 
period as may be determined, to comply with the requirements of this Act. 
SECTION 
9. 
IMPLEMENTING RULES AND REGULATIONS. – The 
departments and agencies charged with carrying out the provisions of this Act 
shall, within sixty (60) days after the effectivity of this Act, formulate the 
necessary rules and regulations for its effective implementation. 
SECTION 
10. 
REPEALING CLAUSE. – All laws, decrees, executive 
orders, rules and regulations, or parts thereof inconsistent with the provisions 
of this Act are hereby repealed or modified accordingly. 
SECTION 
11. 
SEPARABILITY CLAUSE. – If, for any reason, any 
section or provision of this Act is held unconstitutional or invalid, the other 
sections or provisions hereof shall not be affected thereby. 
SECTION 
12. 
EFFECTIVITY CLAUSE. – This Act shall take effect 
after fifteen (15) days from its publication in the Official Gazette or in at least two 
(2) national newspapers of general circulation whichever comes earlier. 


Approved,