9711 Flashcards by Marianne Nadeen Aini Tupay

It strengthens and rationalizes the regulatory capacity of the Bureau of Food and Drugs (BFAD) by establishing adequate testing
laboratories and field offices, upgrading equipment, augmenting human resources, and giving
authority to retain income.

Republic Act No. 9711, signed on August 18, 2009,

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The Four Regulatory C enters

Center for Drug Regulation and
Research

Center for Device Regulation,
Radiation Health, and Research

Center for Food Regulation and
Research

Center for Cosmetics Regulation
and Research

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Regulates drugs, veterinary medicine, vaccines, and biologicals to ensure safety, efficacy, and
quality.

Center for Drug Regulation and
Research

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Monitors medical devices, radiation devices, and health- related devices for safety and effectiveness.

Center for Device Regulation,
Radiation Health, and Research

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Oversees food products to ensure they meet safety and quality standards for human consumption.

Center for Food Regulation and
Research

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Regulates cosmetics and household/urban hazardous substances to protect consumer safety

Center for Cosmetics Regulation
and Research

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Evaluates health products and establishments for authorization issuance

Licensing and Registration Division

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Conducts research and develops standards to ensure product safety

Product Research and Standards Development Division

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Performs tests, calibration, analyses, and trials of products

Laboratory Support Division

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Each of the four regulatory centers is headed by a

director

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Heads the FDA with rank of Undersecretary

Director-General

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The FDA is structured with a Director-General at the top, assisted by two:

Deputy Directors-General

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Current Director-General

Dr Samuel A Zacate

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Current Deputy Director-General for Internal Management

Atty Ronald R De Veyra

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Current Deputy Director-General for Field Regulatory Operations Office

Jesusa Joyce N Cirunay

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Must possess a university degree in medicine or relevant master’s degree in pharmaceutical sciences or allied sciences, with management experience in the field and regulatory work.

Director-General

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Must be a certified public accountant or possess a master’s degree in accounting, management, economics or business, with relevant management experience.

Deputy Director-General for Administration and Finance

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Must possess relevant master’s degree in pharmaceutical sciences or allied sciences, with management experience in the field and regulatory work.

Deputy Director-General for Field Operations

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It is required for those previously employed in regulated establishments, with mandatory disclosure of income and
conflicts of interest.

Three-year cooling period

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Any processed substance intended for human consumption including drinks, beverages, chewing gum and
substances used as ingredients
in food manufacturing, preparation or treatment.

Food

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Articles recognized in official
pharmacopeias, intended for
diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body of humans or animals.

Drug

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Includes medical devices, radiation devices, and health-related devices intended for diagnosis, prevention,
monitoring, treatment, or
alleviation of disease or injury.

Device

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Any substance intended to be
placed in contact with external
parts of the human body or teeth and oral cavity for cleaning, perfuming, changing appearance, and/or protecting
the body.

Cosmetics

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analysis to determine the (1) presence of a substance and the amount of that substance, or
(2) the pharmaceutical potency of a drug

Assay

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permission granted by the FDA to implement the manufacture, importation, exportation, sale, offer for sale, distribution, transfer of products which can take the form of a permit, a license, a certificate of registration, of accreditation, of compliance, or of exemption, or any similar document.

Authorization

Penalties for Individuals

Imprisonment of 1-10 years or a fine of ₱50,000-₱500,000, or both, at the court's discretion.

Penalties for Manufacturers/Importers

Imprisonment of at least 5 years but not more than 10 years and a fine of ₱500,000-₱5,000,000.

Continuing Violations

Additional fine of 1% of the economic value/cost of the violative product or ₱1,000 (whichever is higher) for each day of continuing violation.

Administrative Sanctions

Authorization Cancellation Financial Penalties Product Destruction Establishment Closure

RA 9711 shall be known as the

"Food and Drug Administration (FDA) Act of 2009"

The Administration and Finance Office headed by the deputy director-general for administration and finance shall have, at least, the following divisions:

the Human Resource Development Division; Property and Logistics Management Division; Human Resource Management Division; Assets and Financial Management Division; Information and Communication Technology Management Division.

This office which shall be under the Office of the Director- General shall have, at least, a training, advocacy and communications division and shall monitor the performance of the centers for product research and evaluation and standards development.

The Policy and Planning Office

It is headed by the deputy director-general for field regulatory operations shall include, among others, all the field offices, field or satellite laboratories and the regulatory enforcement units.

The Field Regulatory Operations Office

They shall provide legal services to the entire FDA and shall be directly under the Office of the Director-General.

The Legal Services Support Center

The director-general shall be assisted by two (2) deputy directors-general:

one for administration and finance another for field regulatory operations.

The director-general and deputy directors-general shall be appointed by the:

President of the Republic of the Philippines

Each center and field office shall be headed by a __ who shall be assisted by an assistant __. These shall be appointed by the:

director Secretary of Health

It means any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material, or other similar or related article intended by the manufacturer to be used alone, or in combination, for human beings for one or more of the specific purpose(s)

Medical device

It means an electrical or electronic apparatus emitting any ionizing or non-ionizing electromagnetic or particulate radiation; or any sonic; infrasonic, or ultrasonic wave. I

Radiation device

It means any device not used in health care but has been determined by the FDA to adversely affect the health of the people.

Health-related device

It means a display of written, printed, or graphic matter upon, the immediate container of any article and a requirement made by or under authority of this Act that any word, statement, or other information appearing on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or easily legible through the outside container or wrapper.

Label

It means the delivery or sale of any health product for purposes of distribution in commerce, except that such term does not include the manufacture or retail of such product.

Distribute

in relation to a health product, means an establishment engaged in any and all operations involved in the production of health products including preparation, processing, compounding, formnlating, filling, packing, repacking, altering, ornamenting, finishing and labeling with the end in view of its storage, sale or distribution

Manufacturer

It means drugs intended for use for animals including any drug intended for use in animal feeds but not including animal feeds within the contemplation of the implementing rules and regulations.

Veterinary drugs

It means the rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a drug and becomes available at the site of drug action.

Bioavailability

It means the rate and extent of absorption to which the drugs do not show a significant difference from the rate and extent of the listed drug when administered at the same molar dose of the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses.

Bioequivalence

shall also refer to the absence of a signiticant difference on the rate and extent-to- which the active ingredient(s) of the sample and reference drug becomes available at the site of drug action when administered under the same molar dose and under similar conditions.

Bioequivalence

It means any establishment that imports or exports raw materials, active ingredients and/or finished products for its own use or for wholesale distribution to other establishments or outlets. If they sell to the general public, it shall be considered a retailer

Distributor/importer/exporter

It means any establishment that procures raw materials, active ingredients and/or finished products from local establishments for local distribution on wholesale basis.

Distributor/wholesaler

It means a sole proprietorship, a partnership, a corporation, an institution, an association, or an organization engaged in the manufacture, importation, exportation, sale, offer for sale, distribution, donation, transfer, use, testing, promotion, advertising, or sponsorship of health products including the facilities and installations needed for its activities.

Establishment

It means a processed food product intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamin, mineral, herb, or other botanical, amino acid, and dietary substance to increase the total daily intake in amounts conforming to the latest Philippine recommended energy and nutrient intakes or internationally agreed minimum daily requirements.

Food/dietary supplement

It means food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents and household/urban hazardous substances and/or a combination of and/or a derivative thereof.

Health products

Any substance or mixture of substances intended for individual or limited purposes and which is toxic, corrosive, an irritant, a strong sensitizer, is flammable or combustible, or generates pressure through decomposition, heat or other means,

Household/urban hazardous substance

Any toy or other articles intended for use by children which the FDA may determine to pose an electrical, chemical, physical, or thermal hazard;

Household/urban hazardous substance

This term shall not apply to food, drugs, cosmetics, devices, or to substances intended for use as fuels when stored in containers and used in the heating, cooking or refrigeration system of a house,

Household/urban hazardous substance

are reagents and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat or prevent disease or its sequelae.

In-vitro diagnostic reagents

It means the process of approval of an application to operate or establish an establishment prior to engaging in the manufacture, importation, exportation, sale, offer for sale, distribution, transfer, and where applicable the use, testing, promotion, advertisement, and/or sponsorship of health products

Licensing

It means, in addition to definitions in existing laws, misinformation or misleading information on the label or other information materials authorized by the FDA. It shall not refer to copyright, trademark, or other intellectual property-like instruments.

Misbranding

It means the process of approval of an application to register health products prior to engaging in the manufacture, importation, exportation, sale, offer for sale, distribution, transfer, and where applicable, the use, testing, promotion, advertisement, and/or sponsorship of health products.

Registration

It means any establishment which is a registered owner of a health product and procures the raw materials and packing components and provides the production monographs, quality control standards and procedures, but subcontract the manufacture of such product to a licensed manufacturer.

Trader

' means any establishment which sells or offers to sell any health product directly to the general public

Retailer

Should the offense be committed by a juridical person, the Chairman of the Board of Directors, the president, general manager, or the partners and/or the persons directly responsible therefore shall he penalized.

Should the offense be committed by a foreign national, he/she shall, in addition to the penalties prescribed, be deported without further proceedings after service of sentence.

Hearings authorized or required by this Act shall be conducted by the.

FDA

Upon preliminary findings of the conduct of prohibited act/s, the __ shall issue the proper notices or orders to the person or persons concerned and such person or persons shall be given an opportunity to be heard before the FDA

director-general

Upon the sole approval of the Secretary, the authorization and other fees shall annually be determined and reviewed by the _ and any proposed increase shall be published in two (2)

FDA leading newspapers of general circulation.

The FDA shall establish a __ for a period not exceeding __from the effectivity of this Act. It shall be composed of at least ___qualified personnel in every region who shall be directly under the control and supervision of the Deputy Director-General for Field Regulatory Operations and shall be administratively supported by the field offices.

Regulatory Enforcement Unit (REU) five (5) years five (5)

All regional regulatory enforcement units shall be headed by a _ who is at least __, an __ member of good standing, and shall have a rank of a __;

lawyer thirty (30) years old but not older than fifty (50) Integrated Bar of the Philippines (IBP) Division Director

For the purpose of achieving the above mandate, there shall be established at least ___testing laboratory each in Luzon, Visayas and Mindanao, which shall have the necessary and appropriate state-of-the-art laboratory equipment and personnel complement.

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9711 Flashcards

(68 cards)