Ra 9711-FDA Act of 2009

7/25/2019 Ra 9711-FDA Act of 2009

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RA 9711: FDA Ac2009

7/25/2019 Ra 9711-FDA Act of 2009


•AN ACT STRENGTHENING AND RATIOTHE REGULATORY CAPACITY OF THEOF FOOD AND DRUGS (BFAD) BY ESTA

ADEQUATE TESTING LABORATORIES AOFFICES, UPGRADING ITS EQAUGMENTING ITS HUMAN RCOMPLEMENT, GIVING AUTHORITY T

ITS INCOME, RENAMING IT THE FODRUG ADMINISTRATION (FDA), ACERTAIN SECTIONS OF REPUBLIC ACTAS AMENDED, AND APPROPRIATIN

THEREOF

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SECTION 1:

RENAMING OF BFAD

•Bureau of Food and Dr

•Food and Drug Admini

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SECTION 3:

POLICY OF THE STATE

•Protect and promote the right to healtFilipino people

•Help establish and maintain an effectiv

products regulatory system and uappropriate health manpower developmresearch responsive to the country’s healand problems.

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SECTION 4:

OBJECTIVES OF THE ACT

• To enhance and strengthen the administr

technical capacity of the FDA in the regu

establishments and products under its jurisdicti

•To ensure the FDA’s monitoring and regulatoryover establishments and products under its juris

• To provide coherence in the FDA’s regulatory s

establishments and promote under its jurisdicti

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SECTION 5:

FUNCTIONS, POWERS AND D

OF FDA• To administer the effective implementation of th

regulations

• To assume primary jurisdiction in the collection of

health products• To analyze and inspect health products

• To establish analytical data to serve as basis for the of health products standards and to recommend s

identity, purity, safety, efficacy, quality and fill of cont

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• To issue certificates of compliance with technical requ

serve as basis for the issuance of appropriate autho

spot check for compliance with regulations

• To conduct appropriate tests on all applicable healprior to the issuance of appropriate authorization

safety, efficacy, purity and quality

• To require all manufacturers, traders, distributors

exporters, wholesalers, retailers, consumers, and nousers of health products to report to the FDA any in

reasonably indicates that said product has caused or

to the death, serious illness or serious injury to a

patient or any person.

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• To issue cease and desist orders motu proprio or up

complaints for health products, whether or not reg

the FDA

• After due process, to order the ban, recall and/or wiany health product and to require all concerned to

risk management plan which is a requirement for the

the appropriate authorization

• To strengthen the post marketing surveillance monitoring health products

• To develop and issue products and appropriate aut

that would cover establishments, facilities and health

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• To conduct, supervise, monitor and audistudies on health and safety issues of healtundertaken by entities duly approved by the F

• To maintain bonded warehouses and/or estsame, whenever necessary or appropdetermined by the director-general for c

goods in strategic areas of the country esmajor ports of entry.

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COSMETICSREGULATION

ANDRESEARCH

FOODREGULATION

ANDRESEARCH

DRUGREGULATION

ANDRESEARCH

SECTION 6:

NEW CENTERS OF FDA

Each Center shall be headed by a director who shall b

by an assistant director

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Director

Licensing andRegistrationDivision

Product

Research andStandardsDevelopment

Division

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ADMINISTRATION ANDFINANCE OFFICE

HUMADEV

PROPERT

MAN

HUMAMAN

FINANCIA

INFORCOMM

TECHNOLO

DEPUTY DIRECTOR

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DIRECTOR GENERAL

Deputy Director General for

administration and finance

Deputy Director for field regulatoryoperations

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OFFICE OF THEDIRECTOR-GENERAL

Policy and Planning Office

Legal Services Support Ce

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QUALIFICATIONS

• DIRECTOR GENERAL

- Degree in Medicine or at least the relevant master’spharmaceutical sciences or allied sciences, or equivalent cregulatory management

• DEPUTY DIRECTOR-GENERAL FOR FIELD REGULATORY OP

- Master’s Degree in pharmaceutical sciences or allied sciences executive course in any regulatory management.

• DEPUTY DIRECTOR-GENERAL FOR ADMINISTRATION AND

- Certified public accountant or shall possess a master’s degree inmanagement, economics or any business course

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RA 3720 RA 9711

Imprisonment of not less thanone (1) year but not more than

five (5) years

Imprisonment rang(1) year but not mo

(10) year

Fine of not less than 5,000 pesosbut not more than 10,000 pesos,

or both such imprisonment and

fine, in the discretion of theCourt

Fine of not less tthousand pesos (P50

not more than Fiv

thousand pesos (P

SECTION 12:

PENALTIES

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• If the offender is a manufacturer, importer or

of any health product:

PENALTY – at least five (5) years imprisonmemore than ten (10) years and a fine of at least fiv

thousand pesos (P500,000.00) but not more

million pesos (P5,000,000.00) shall be imposed.

ADDITIONAL fine of 1% of the economic value/violative product or violation, or one thous

(P1,000.00), whichever is higher, shall be impose

day for continuing violation

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• Should the offense be committed by a juridic

the Chairman of the Board of Directors, the

general manager, or the partners and/or persoresponsible therefore shall be penalized.

• Should the offense be committed by a foreig

he/she shall in additional to the penalties pres

deported without further proceedings after sentence.

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SECTION 13:

ADMINISTRATIVE SANCTIO

• Cancellation of any authorization which may have been gFDA, or suspension of the validity for such period of time ageneral may deem reasonable which shall not exceed one

• Fine not less than fifty thousand pesos (P50,000.00) but five hundred thousand pesos (P500,000.00). An additio

more than one thousand pesos (P1,000.00) shall be impday of continuing violation

• Destruction and/or appropriate disposition of the sproduct, and/or closure of the establishment for any violatas determined by the director-general

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SECTION 14:

ADDITIONAL POWERS AND FUNCT

THE DIRECTOR-GENERAL

• To hold in direct or indirect contempt any person w

orders or writs he or she issues and impose the appro

following the same procedures and penalties provid

of Court

• To administer oaths and affirmations and issue s

tecum and subpoena ad testificandum

• To obtain information from any officer or office of

local governments, government agencies and its instr

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• To issue orders of seizure, to seize and hold i

any article or articles of food, device, c

household hazardous substances and health

that is adulterated, counterfeited, misbra

unregistered, or drug, in-vitro diagnostic

biological, and vaccine that is adulterated or mwhen introduced into domestic commerce

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• To call on the assistance of any departmeor agency and deputize members of the PNational Police or any law enforcement athe effective implementation of this Act

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SECTION 17:

FEES AND OTHER INCO

•Upon the sole approval of the Secreauthorization and other fees shall andetermined and reviewed by the FDAproposed increase shall be published ileading newspapers of general circulation

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• All income that the FDA is allowed tshall be deposited in an aut

government depository bank as a

regulatory fund .

SECTION

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SECTION 19:

ESTABLISHMENT OF REU

•The FDA shallestablish a RegulatoryEnforcement Unit

(REU) for a period notexceeding five (5)years from theeffectivity of this Act.

REU

Deputy

DirectorGenera

5 qualifiepersonnel

every regi

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R

E UBear arms,

wear officialuniforms andinsignias andshall beclassified as

lawenforcementagents

R

E UServe and

executerulings, orders,and decisionsof theDirector-

General of theFDA

R

E UExe

servwaarreissucou

conwit

SECTION 20:

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SECTION 20:

TESTING LABORATORY AND F

OFFICES

• FDA is hereby mandated to improve, up

increase the capability of the agency, to test

assay and examine samples of health products.

• there shall be established at least one laboratory each in Luzon, Visayas and Minda

shall have the necessary and appropriate state

laboratory equipment and personnel compleme

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•The main testing laboratories at the censhall be maintained and shall serve as

unit to the centers for product reseaevaluation and standards development.

• The existing laboratories in Cebu and D

be upgraded and transformed as quality laboratories, while another one will be ein Subic, Zambales.

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•The FDA shall establish field offiregions of the country to ef

implement its regulatory function

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SECTION 28:

EFFECTIVITY

•This Act shall take effect fifteen (1

after its publication in the Official Gain two (2) newspapers of general circu

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June 3, 2009

Quiz on RA 9711

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Quiz on RA 9711

1. The collective term used to refer to any incident that reasonabthat a particular product has caused or contributed to the deatillness or serious injury to a consumer, patient or any person.

2. The term _______is used to refer to a decision by FDA to initiainvestigation into a situation on their own initiative.

3. The increased fine applicable for retailers who violate RA 3720

4. The increased fine applicable for manufacturers, importers, or

who violate RA 37205. The unit established in every region of the country to strength

regulatory capacity of FDA

Quiz on RA 9711

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Quiz on RA 97116. Should the offense be committed by a juridical person, _______

penalized.

7. Which previous division of FDA had been replaced by drug, devicosmetics and food REGULATION AND RESEARCH

Indicate what divisions of FDA will perform the following functions:

8. To assume primary jurisdiction in the collection of samplproducts

9.To analyze and inspect health products

10. To establish analytical data to serve as basis for the preparatproducts standards and to recommend standards of identity, pefficacy, quality and fill of container

Documents

Ra 9711-FDA Act of 2009