Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

SEVENTEENTH CONGRESS
Third Regular Session

House Bill No. 8002

Introduced by REPRESENTATIVE ARTHUR C. YAP

EXPLANATORY NOTE

The Philippines, being identified as one of the countries with the most
diverse natural resources, has an important stake in the development of its own
alternative medicines, particularly those derived from plant sources. The Food
and Drug Administration (FDA) is the government agency which has the
regulatory power over the production, distribution and use of these health
products.

According to a research article written by Yolanda Robles et al and
published in the Journal of Asian Association of Schools of Pharmacy, the
traditional medicine (TM) and herbal supplement (HS) industry can learn from
other countries with highly developed regulatory systems for such products. The
proliferation of unregistered products of variable quality must be tackled by a
more rigorous regulation of the government in the interest of public safety. This
present need is even more compounded by the recent movement towards
harmonizing regulatory processes among ASEAN countries. The Philippines
must be prepared to bring to the regional forum those policies which protect the
regional and national interests while being sensitive to the concerns of the local
herbal industry and the Filipino people.

‘The alignment of FDA regulations and provisions of RA 8423, otherwise
known as the Traditional and Alternative Medicine Act (TAMA), is envisioned
to strengthen the position of the local food supplement and herbal medicine
industry in responding to the country’s health needs.

However, despite the new FDA law (RA 9711) being passed, there is no
single unit dedicated to the screening, evaluation and processing of technical
documents and other regulatory requirements for these group of products. They
are either processed with applications for conventional medicines or with
applications for food items.

The creation of a center exclusively devoted to traditional and alternative
under the FDA will streamline and expedite registration procedures to facilitate
the release of product registration certificates. Similar to other centers, it shall
also be headed by a director with the following divisions:


iii.

Licensing and Registration Division, which shall be responsible
for evaluating health products and establishments as covered by
this Act for the purpose of issuance of authorizations and
conditions to be observed;

Product Research and Standards Development Division, which
shall be responsible for the 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, as covered in this
Act; and

Laboratory Support Division, which shall be responsible for the
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 as covered
by this Act. It shall likewise provide direct line support to the
centers which shall be separate and distinct per major product
category that is regulated.

The composition will include experienced researchers on traditional

medicines, FDA clerical staff, and practitioners of TM/HS with no competing
interests. Alternative medicine practitioners or certified herbalists should be
chosen to be part of evaluation teams, instead of medical doctors and
conventional medicine practitioners.

As for the scientific validity criteria, the minimum requirements for

establishing the claims of TM and HS should include at least chemical tests to
prove the presence of constituents responsible for the claims made.

In view of the foregoing, immediate passage of this bill is earnestly sought.

Hon. AR’ CAP’
R itative
3" District, Bohol


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Republic of the Philippines
HOUSE OF REPRESENTATIVES

Quezon City

SEVENTEENTH CONGRESS
Third Regular Session

House Bill No. __ 8002

Introduced by REPRESENTATIVE ARTHUR C. YAP

AN ACT
AMENDING REPUBLIC ACT 9711, OTHERWISE KNOWN AS THE
"FOOD AND DRUG ADMINISTRATION ACT" AND FOR OTHER
PURPOSES

Be it enacted by the Senate and House of Representatives of the Philippines in
Congress assembled:

SECTION 1. Section 6 of Republic Act No. 9711, as amended, is hereby
further amended and new subsections are added to read as follows:

"SEC. 5. The FDA shall have the following centers and offices:

"(a) The Centers shall be established per major product category that is
regulated, namely:

"(1) Center for Drug Regulation and Research (to include
veterinary medicine, vaccines and biologicals);

"(2) Center for Food Regulation and Research;

"(3) Center for Cosmetics Regulation and Research (to include
household hazardous/urban substances); and

"(4) Center for Device Regulation, Radiation Health, and
Research.

“(5) CENTER FOR TRADITIONAL AND ALTERNATIVE
MEDICINE.

"These Centers shall regulate the manufacture, importation, exportation,
distribution, sale, offer for sale, transfer, promotion, advertisement,
sponsorship of, and/or, where appropriate, the use and testing of health
products. The conduct research on the safety, efficacy, and quality of
health products, and to institute standards for the same.

"(b) Each Center shall be headed by a director. The Centers shall be so
organized such that each will have, at least, the following divisions:


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"(1) Licensing and Registration Division, which shall be responsible for
evaluating health products and establishments as covered by this Act for
the purpose of issuance of authorizations and conditions to be observed;

(2) Product Research and Standards Development Division, which shall
be responsible for the 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, as covered in this Act; and

"(3) Laboratory Support Division, which shall be responsible for the
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 as covered by this Act. It shall
likewise provide direct line support to the centers which shall be separate
and distinct per major product category that is regulated.

SECTION 2. Implementation. - The FDA, in coordination with PITAHC,

shall issue implementing rules and regulations as may be necessary to carry out

the purpose of this Act within ninety (90) days from effectivity hereof.

SECTION 3. Separability Clause. - The provisions of this Act are hereby
declared separable. If any portion thereof shall be held invalid unconstitutional,
such invalidity or unconstitutionality shall not affect the other provisions which

shall remain in full force and effect.

SECTION 4. Repealing Clause. — All laws, executive orders, letters of
instructions, rules and regulations, or provisions thereof, which are inconsistent
with the provisions of this Act are hereby repealed, amended or modified
accordingly.

SECTION 5. Effectivity Clause - This Act shall take effect within fifteen (15)
days after its complete publication in the Official Gazette or in at least two (2)

newspapers of general circulation.