Republic Act . No.

9711
August 18, 2009

AN ACT STRENGTHENING AND

RATIONALIZING THE REGULATORY
CAPACITY OF THE BFAD BY
ESTABLISHING ADEQUATE TESTING
LABORATORIES AND FIELD OFFICES,
UPGRADING ITS EQUIPMENT,
AUGMENTING ITS HUMAN RESOURCE
COMPLEMENT, GIVING AUTHORITY TO
RETAIN ITS INCOME, RENAMING IT AS
FOOD AND DRUG ADMINISTRATION
(FDA), AMENDING CERTAIN SECTIONS
OF RA No. 3720, AS AMENDED, AND
 Salient Features of the Law
• BFAD is renamed as Food and Drug
Administration (FDA)
• FDA shall be under the office of the
Secretary of Health
• Duties and responsibilities of the
FDA was increased/ emphasized
• Definition of terms and punishable
acts modified, penalties increased
 Definition of Terms

Food
Drug
Device - Medical device, radiation device, health-
related device
Cosmetics
Label
Distribute
Manufacture
 Definition…

Veterinary drugs
Assay
Bioavailability
Bioequivalence (n)
Distributor/importer/exporter (n)
Distributor/wholesaler (n)
Establishment (n)
 Definition…
Food/dietary supplement (n)
Health products (n)
Household/ urban hazardous substances (n)
In-vitro diagnostic reagents (n)
Licensing (n)
Misbranding
Salient…
• Headed by a director general having the
rank of an undersecretary , aided by 2
deputy director generals
• Merging of BFAD and BHDT
• Current BFAD director to head the FDA
• Current BHDT director as one of the
deputy DG.
 Salient…
4 Centers , each to be headed by a director
• Center for DRUG regulation and research
• Center for FOOD regulation and research
• Center for COSMETICS regulations and
research
• Center for DEVICE regulations, radiation
health and research
Salient…
Each center will have the following divisions
• Licensing and registration division
• Product research and standards development
division
• Laboratory support division
• Administrative and finance office
• Policy and planning office
Salient….

• Existing directors of BHDT & division

chiefs of BFAD- given preference for
appointment as directors & assistant
directors of their respective centers (3
years to acquire 3rd level CS eligibility)

• FDA staffing pattern to be approved by

the SOH
Salient…
• Definition of terms – revised, added terms
• Punishable acts (Sec. 11) amended
• Provision of funds for legal assistance to
FDA personnel in the exercise of their
duties
• Cebu & Davao Satellite laboratories + 1
in Subic, Zambales
Salient…

• Penalties – increased
1- 10 years imprisonment +
Fine- 50K to 500K

5-10 years imprisonment +

Fine of 500K to 5 M
Salient…
• Establishment of a Regulatory
Enforcement Unit (REU) – for a period not
exceeding 5 years from the effectivity of
the Act
• Composed of at least 5 personnel per
region
• Headed by a lawyer (rank of a Division
Director) & an assistant (at least law
graduate, w/ the rank of Assistant Division
Director)
Salient…
Under the Deputy DG for Field Regulatory
operations & administratively supported
by the field offices
• Bear arms, wear official uniforms & insignias
& shall be classified as law enforcement
agents
• Serve & execute ruling, orders & decisions of
the DG
• Execute & serve search warrants & arrest
warrants
• Undergo appropriate training
 Transitory Provisions
• Current officials & employees of BFAD-
transferred as far as practicable to the
appropriate unit in the FDA as determined
by the DG

• Current BHDT officials & employees shall

be transferred to the Center for Device
Regulation, Radiation Health, and
Research
Transitory…
• Current regional FDROs & regional
health physicists shall be transferred to
the appropriate unit in the FDA as
determined by the DG
• No demotion in ranks & positions
• No diminution in salaries, benefits,
allowances & emoluments
Transitory…
• All positions, powers, functions & duties
together with the facilities, equipment,
supplies, records , files, appropriations,
and funds for these bureaus & the CHD
personnel shall be transferred to the FDA.