Republic of the Philippines 
HOUSE OF REPRESENTATIVES 
Quezon City 
NINETEENTH CONGRESS 
Second Regular Session 
HOUSE BILL NO. ____ 
Introduced by HON. LUIS RAYMUND “LRAY” F. VILLAFUERTE, JR. 
EXPLANATORY NOTE 
The Constitution, Article 2, Section 13 provides that: 
“The State shall establish and maintain an effective food and drug regulatory 
system and undertake appropriate health manpower development and 
research, responsive to the country’s health needs and problems.” 
Republic Act No. 6675, also known as the Generics Act of 1998, requires the use of 
generic terminologies in prescription of drugs. However, such requirement is not 
sufficient as drugs, having the same generic term, may have different active 
ingredients. 
This bill aims to establish therapeutic equivalence requirements for the generic drugs, 
in order to ensure that the drug products with similar generic name also contain the 
same chemical components responsible for the claimed therapeutic effect. 
LUIS RAYMUND “LRAY” F. VILLAFUERTE, JR. 
August 3, 2023
12:01 pm
8747


Republic of the Philippines 
HOUSE OF REPRESENTATIVES 
Quezon City 
NINETEENTH CONGRESS 
Second Regular Session 
HOUSE BILL NO. ____ 
Introduced by HON. LUIS RAYMUND “LRAY” F. VILLAFUERTE, JR. 
AN ACT 
TO ESTABLISH THERAPEUTIC EQUIVALENCE REQUIREMENTS 
FOR GENERIC DRUGS 
Be it enacted by the Senate and the House of Representatives of the Philippines in 
Congress assembled: 
SECTION 1. Short Title. – This Act shall be known as the “Generic Drug Uniformity 
Act.” 
Sec. 2. Declaration of Policy. – It is the policy of the State to ensure safe and good 
quality of drugs, and regulate their production, in order to protect the health of the 
consumer. 
Sec. 3. Definition of Terms. – For purposes of this Act, the term: 
(A)
“Generic Drugs” means drugs not covered by patent protection and which are
labeled solely by their international non-proprietary or generic name.
(B)
“Generic Name or Generic Terminology” means the identification of drugs and
medicines by their scientifically and internationally recognized active
ingredients or by their official generic name as determined by the Bureau of
Food and Drugs of the Department of Health.
(C)
“Active Ingredient” means the chemical component responsible for the claimed
therapeutic effect of the pharmaceutical product.
(D)
“Essential Drugs List” or “National Drug Formulary” is a list of drugs prepared
and periodically updated by the Department of Health on the basis of health
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conditions obtaining in the Philippines, as well as on internationally accepted 
criteria. It shall consist of a core list and a complementary list.  
(E) 
“Core List” is a list of drugs that meets the health care needs of the majority of 
the population. 
(F) 
“Complementary List” is a list of alternative drugs used when there is no 
response to the core essential drug or when there is a hypersensitivity reaction 
to the core essential drug or when, for one reason or another, the core essential 
drug cannot be given. 
(G) 
“Drug Establishment” means any organization or company involved in the 
manufacture, importation, repacking and/or distribution of drugs or medicines. 
 
Sec. 4. Therapeutic Equivalence. – A drug is the therapeutic equivalent of a drug 
listed in the essential drugs list or National Drug Formulary when, with respect to the 
listed drug — 
(A) 
All of its active ingredients are the same, it is of the same dosage form, it has 
the same route of administration, it is identical in strength or concentration, and 
it meets the same compendial or other applicable standard, except that it may 
differ in shape, scoring, configuration, packaging, expiration time or labeling; 
(B) 
It is expected to have the same clinical effect and safety profile when 
administered to patients under conditions specified in the labeling; and 
(C) 
It either does not present a known or potential bioequivalence problem and 
meets an acceptable in vitro standard or if it does present such a problem, is 
shown to meet an appropriate bioequivalence standard. 
 
If a drug meets the requirements of paragraphs (A), (B) and (C), with respect to an 
essential drugs list, the Department of Health Secretary shall include in the approval 
of the application for the drug that it is the therapeutic equivalent the listed drug 
involved. 
 
Sec. 5. Licensing of Drug Establishment. – When the Secretary approves an 
application for the licensing of drug establishments, he shall include in such approval 
a finding that the drug for which the application is approved is or is not the therapeutic 
equivalent of the listed drug involved.  
 


 
Sec. 6. Separability Clause. – If any provision or part hereof, is held invalid or 
unconstitutional, the remainder of the Act or the provision not otherwise affected shall 
remain valid and subsisting. 
 
Sec. 7. Repealing Clause. – Any law, presidential decree or issuance, executive 
order, letter of instruction, administrative order, rule or regulation contrary to, or 
inconsistent with the provisions of this Act is hereby repealed, modified or amended 
accordingly. 
 
Sec. 8. Effectivity Clause. – This Act shall take effect fifteen (15) days after its 
publication in at least two (2) newspapers of general circulation. 
 
Approved,