Philippines Generic Medicines Regulations
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Questions and Answers

What does Article III, Section 7 of the 1987 Philippine Constitution recognize?

the right of the people to gain information on matters of public concern, such as those relating to health and health products.

What is the role of the Food and Drug Administration (FDA) in the Philippines?

It is responsible for all matters pertaining to drug products.

Which of the following terms refers to a substance intended to be used in the manufacture of a pharmaceutical product?

  • Adverse Drug Reaction (ADR)
  • Active Moiety
  • Active Pharmaceutical Ingredient (API) (correct)
  • Batch Number

    • The Administrative Order is intended to complicate the regulations on labeling of drug products.

    <p>False</p> Signup and view all the answers

    What is an Adverse Drug Reaction (ADR)?

    <p>A response to a medicine that is noxious and unintended, occurring at normal doses.</p> Signup and view all the answers

    The date on the label of a drug product that designates its expected shelf-life is called the ______.

    <p>Expiration Date</p> Signup and view all the answers

    What is a Brand Name in pharmaceuticals?

    <p>The proprietary name assigned to the product by the Marketing Authorization Holder</p> Signup and view all the answers

    What does the term 'lot number' refer to?

    <p>A distinctive combination of letters and/or numbers assigned to a particular lot, defined as a portion of a batch.</p> Signup and view all the answers

    Which of the following is NOT included in the definition of a Biological Product?

    <p>Antibiotics</p> Signup and view all the answers

    What is the definition of a drug product?

    <p>An article intended for use in diagnosis, cure, mitigation, treatment or prevention of disease in humans or animals.</p> Signup and view all the answers

    What is the mode of administration?

    <p>The manner and site where the drug product is to be introduced into or applied on the body.</p> Signup and view all the answers

    What does net content refer to?

    <p>The total amount/quantity/number of the dosage form in a certain container of a drug product expressed in metric system.</p> Signup and view all the answers

    New chemical entities (NCE) are previously authorized for marketing for any pharmaceutical use.

    <p>False</p> Signup and view all the answers

    What are over-the-counter (OTC) drugs?

    <p>Drug products that can be dispensed even without the written order of a licensed physician or dentist.</p> Signup and view all the answers

    What is a package insert?

    <p>The document defining information that is supplied with prescription drug products by the marketing authorization holder (MAH).</p> Signup and view all the answers

    What does the pharmacologic category refer to?

    <p>The classification of the drug product based on its therapeutic action as specified in the product registration.</p> Signup and view all the answers

    What is the purpose of the patient information leaflet (PIL)?

    <p>To provide information for patients supplied with non-prescription drug products.</p> Signup and view all the answers

    What is a prodrug?

    <p>A drug substance that is inactive and must be converted into the pharmacologically active agent by metabolic or physico-chemical transformation.</p> Signup and view all the answers

    What information must labels for drug products include?

    <p>Product name, dosage form and strength, pharmacologic category, formulation/composition, indications, dosage and mode of administration, contraindications, precautions, warnings, interactions, adverse drug reactions, overdose and treatment, storage conditions, net content or pack size, name and address of MAH, name and address of manufacturer, Rx symbol, ADR reporting statement, registration number, batch number and lot number, expiration date and date of manufacture.</p> Signup and view all the answers

    What does the registration number indicate?

    <p>A combination of letters and/or numbers assigned to a particular drug product by FDA as proof of registration.</p> Signup and view all the answers

    Which of the following are considered small containers?

    <p>All of the above</p> Signup and view all the answers

    What does 'storage conditions' refer to?

    <p>The acceptable specified temperature range, humidity, and other environmental factors within which optimal stability of the drug product is ensured.</p> Signup and view all the answers

    What should the label specify regarding dosage strength?

    <p>Expressed in metric units reduced to lowest terms</p> Signup and view all the answers

    What are the requirements for the generic name on the product label?

    <p>The generic name shall be as the active moiety based on the International Non-proprietary Name (INN) and consistent with the dosage strength indicated.</p> Signup and view all the answers

    What should the label contain regarding contraindications of the drug product?

    <p>Full information regarding the contraindication(s) of the drug product.</p> Signup and view all the answers

    What warning statement must be included on labels as specified by the FDA?

    <p>'Flammable,' 'For external use only,' 'Keep out of reach of children.'</p> Signup and view all the answers

    What must the label indicate if the contents of a container are intended for single use only?

    <p>All of the above</p> Signup and view all the answers

    What types of interactions must be included on the label?

    <p>Drug-drug, drug-food, drug-laboratory testing interactions.</p> Signup and view all the answers

    What information should be included regarding adverse drug reactions?

    <p>Detailed information arranged by system organ class.</p> Signup and view all the answers

    What does the label need to include in case of overdose?

    <p>Signs and symptoms of overdose and possible treatment.</p> Signup and view all the answers

    What must be included on the label regarding storage conditions?

    <p>Appropriate storage conditions and special instructions for handling.</p> Signup and view all the answers

    What should the unit carton indicate about pack size?

    <p>The pack size expressed in terms of the number of units in the pack or volume of each unit.</p> Signup and view all the answers

    What is required on the label about the marketing authorization holder?

    <p>The name and full address of the marketing authorization holder.</p> Signup and view all the answers

    What is required on the label regarding the manufacturer's information?

    <p>The name and full address of the manufacturer.</p> Signup and view all the answers

    The Rx symbol must always be included on the labeling materials of prescription drug products.

    <p>True</p> Signup and view all the answers

    A caution statement regarding dispensing without a prescription is optional on prescription drug labels.

    <p>False</p> Signup and view all the answers

    What must the label state regarding adverse drug reaction reporting?

    <p>Report to the FDA at <a href="http://www.fda.gov.ph">www.fda.gov.ph</a>.</p> Signup and view all the answers

    What should the label indicate regarding the registration number?

    <p>The registration number assigned by the FDA.</p> Signup and view all the answers

    What must the label indicate about expiration dates?

    <p>The month and year of the product's manufacturing and expiration date.</p> Signup and view all the answers

    What should labeling for parenterals include?

    <p>Both A and B</p> Signup and view all the answers

    Fluid replacement products are exempt from FDA guidelines.

    <p>False</p> Signup and view all the answers

    What statement must appear on external use products?

    <p>For external use only</p> Signup and view all the answers

    What additional information should biological products include?

    <p>The name of the species of animal or organism used in preparation.</p> Signup and view all the answers

    What must physician's samples include on their labeling?

    <p>Batch and/or lot numbers, date of manufacture, and expiration date.</p> Signup and view all the answers

    Drugs under Maximum Drug Retail Price (MDRP) control are required to have specific statements on their labels.

    <p>True</p> Signup and view all the answers

    What are some exemptions from the labeling requisites?

    <p>Drug products manufactured for export, veterinary drug products, and investigational products.</p> Signup and view all the answers

    Study Notes

    Rationale

    • The 1987 Philippine Constitution recognizes the right to information about public health and products.
    • Labels and labeling materials serve as primary information sources for consumers about drug safety, effectiveness, and quality.
    • The Food and Drug Administration (FDA) regulates drug product information and has issued guidelines to enhance accuracy.
    • Globalization and harmonization in ASEAN have identified gaps in existing regulations, necessitating clearer labeling guidelines.

    Objectives

    • To rationalize and update the regulations on generic labeling of drug products in line with ASEAN harmonized requirements.
    • Aims to provide comprehensive guidelines for manufacturers and distributors of drugs.

    Scope

    • Applies to all manufacturers and distributors of drug products for human use, including herbal and traditional medicines.

    Definition of Terms

    • Active Moiety: Molecule responsible for drug action, excluding appended portions.
    • Active Pharmaceutical Ingredient (API): Substances used as therapeutically active compounds in drugs.
    • Adverse Drug Reaction (ADR): Noxious and unintended responses to medications.
    • Batch: Defined quantity of product expected to be homogeneous, crucial for quality control.
    • Batch Number: Unique identifier for batches of products.
    • Biological Product: Includes vaccines and blood products, focuses on higher molecular weight substances.
    • Brand Name: Proprietary name assigned by the Marketing Authorization Holder (MAH).
    • Contraindication: Conditions under which a drug may harm the patient.
    • Date of Manufacture: Month and year when the bulk product processing is completed.
    • Dosage: Quantity of a medication administered at one time.
    • Dosage Form: Physical form of the drug (e.g., tablet, capsule).
    • Dosage Strength: Concentration of API in a formulation, gives indication of therapeutic potency.
    • Drug Product: Any recognized article intended for the diagnosis or treatment of diseases.
    • Excipient: Non-active ingredients added to stabilize or add volume to a drug formulation.
    • Expiration Date: Date before which a product is expected to meet quality specifications.
    • Formulation: Composition of all APIs and excipients present in the drug.
    • Generic Name: Internationally recognized name of an API determined by the FDA.
    • Indication: FDA-approved use based on evidence of safety and efficacy.
    • Investigational Product: Product being tested in a clinical trial or not used as authorized.
    • Label: Information affixed to drug products for identification and usage guidance.
    • Labeling Materials: Additional printed materials accompanying the drug product for consumer information.
    • Lot Number: Identifier assigned to a specific portion of a batch.
    • Manufacturer: Establishment involved in production and release of finished health products.
    • Marketing Authorization (MA): Official document allowing product marketing after safety and efficacy assessment.
    • Marketing Authorization Holder (MAH): Entity responsible for product compliance with regulations.
    • Mode of Administration: Method of delivering the drug product to the body.
    • Net Content: Quantity of drug in a container measured in metric system.
    • New Chemical Entity (NCE): API not previously authorized for marketing in the country.
    • Over-the-Counter (OTC) Drugs: Products available without a physician’s prescription.
    • Pack Size: Quantity of dosage in final packaging.
    • Package Insert (PI): Information supplied with prescription drugs for healthcare professionals.
    • Patient Information Leaflet (PIL): Information supplied with non-prescription drugs aimed at patients.
    • Pharmacologic Category: Classification based on therapeutic action.
    • Precautions: Guidelines to ensure the safe and effective use of the drug.### Prescription Drug Products
    • Dispensation requires a written order from a licensed physician or dentist.
    • Used for managing or treating diagnosed diseases and conditions in humans.

    Primary Label

    • The label on the primary packaging of the drug product.

    Prodrug

    • An inactive drug substance that needs metabolic or physico-chemical transformation to convert into an active agent.

    Product Name

    • Includes generic and brand names as registered by the FDA.

    Product Description

    • A complete organoleptic description of the finished drug product.

    Registration Number

    • A unique combination of letters/numbers assigned by the FDA indicating registration status.

    Small Containers

    • Hold ≤ 5 mL volume or 5 g weight; include ampoules, vials, jars, and packaging for specific formulations.

    Storage Condition(s)

    • Specifies the temperature, humidity, and environmental factors that ensure optimal stability.

    Summary of Product Characteristics (SPC)

    • Approved product information; serves as info source for health personnel and consumers.

    Warnings

    • Notices regarding potential hazards, undesirable effects, and limitations of drug use.

    Mandatory Labeling Information

    • Product Name
    • Dosage Form and Strength
    • Pharmacologic Category
    • Formulation/Composition
    • Indications
    • Dosage and Mode of Administration
    • Contraindications, Precautions, Warnings
    • Interactions
    • Adverse Drug Reactions
    • Overdose and Treatment
    • Storage Conditions
    • Net Content or Pack Size
    • Name and Address of Marketing Authorization Holder (MAH)
    • Name and Address of Manufacturer
    • Rx Symbol and Caution Statement (for prescription drugs)
    • Adverse Drug Reaction Reporting Statement
    • Registration Number
    • Batch Number and Lot Number
    • Expiration Date and Date of Manufacture

    Labeling Requirements

    • Information must be in English and/or Filipino.
    • Must be legible without strain, considering color contrast and spacing.

    Specific Guidelines for Mandatory Information

    • Product Name: Must include the generic and brand name; the generic name should be prominent and enclosed in an outline box.
    • Dosage Form and Strength: Specify the form (tablet, capsule, etc.) and strength in the largest unit metric.
    • Pharmacologic Category: As determined by the FDA.
    • Formulation/Composition: Include all active ingredients per unit dose listed by pharmacologic activity.
    • Indication(s): Include only FDA-approved uses.
    • Dosage and Mode of Administration: Full recommended dosage, administration directions, and special population instructions.
    • Contraindication(s), Precaution(s), Warning(s): Full information on contraindications and precautions required by FDA.
    • Interactions: Drug interactions must be clearly stated.
    • Adverse Drug Reaction(s): Detailed information organized by system organ class.
    • Overdose and Treatment: Signs of overdose and treatment options must be indicated.
    • Storage Condition(s): Appropriate handling and storage instructions must be clear and informative.
    • Pack Size or Net Content: Must reflect quantity or volume in metric units.
    • Name and Address of MAH: Required for traceability.
    • Name and Address of Manufacturer: Essential for quality control and transparency.
    • Rx Symbol and Caution Statement: Required on prescription drug labels for clear identification.

    Additional Labeling Guidelines

    • Product information can be printed on packaging if sold without inserts.
    • Labels must comply with regulations during renewal of Marketing Authorization.
    • Alcohol content, colorants, antimicrobial agents, and preservatives must be listed if present. ### Labeling Requirements for Prescription Drugs
    • The Rx symbol may be over-printed if it does not hinder the legibility of other important labeling information.
    • Caution statement: "Foods, Drugs, Devices, and Cosmetics Act prohibits dispensing without prescription" must be included on the package insert, primary label, and unit carton, except for small containers and blister packs.
    • Dangerous Drugs must display an additional caution statement as specified by the Philippine Drug Enforcement Agency (PDEA).

    Adverse Drug Reaction Reporting

    • Product information sheets and primary labels must include the statement: "For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph".
    • Patients must be advised to seek immediate medical attention for suspected adverse reactions.

    Product Registration and Identification

    • Labels must indicate the FDA registration number, which consists of letters and/or numbers.
    • A batch number is required; if multiple drug establishments market a batch, both batch and lot numbers must be indicated.

    Expiration and Manufacture Dates

    • Labels must state the month and year of manufacturing and expiration dates clearly, either in numeric or written form.
    • If no specific day is mentioned, the last day of the given month is deemed the expiration date.
    • For products needing reconstitution or multiple administrations, guarantees for safety, efficacy, and quality must be specified.

    Special Labeling Instructions by Product Type

    • Parenterals: Include mode of administration (e.g., "IV", "IM"), and instructions on diluting concentrated solutions.
    • Fluid Replacement Products: Must list components and their concentrations, osmolality, and pH values.
    • External Use Products: Must state "For external use only" in capital letters against a red background.
    • Biological Products: Must include species of origin and adjuvants that modify immune response.
    • Multivitamin/Mineral Products: Must identify the generic names and list ingredients accordingly, with emphasis on additional non-vitamin/mineral components.
    • Physician's Samples: Each unit must feature batch/lot numbers, manufacture, and expiration dates. Labels must state "Physician's Sample. Not for Sale" prominently.
    • Drugs under Maximum Drug Retail Price (MDRP): Label must have clear statements regarding price regulation in red font/background.
    • Reproductive Health Products: Must include product information both in English and Filipino/local dialect.

    Exemptions from Labeling Requirements

    • The guidelines do not apply to:
      • Drug products manufactured for export.
      • Veterinary drugs.
      • Products in transparent coverings with visible required particulars.
      • Compounded products by pharmacists for immediate use according to prescriptions.
      • Investigational products.
      • Foreign donations of drug products.
      • Products needing special handling or cold chain management.
      • Low volume importations.

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    Related Documents

    Administrative Order No. 2016-0008 Labeling PDF

    Description

    This quiz covers the Revised Rules and Regulations governing generic medicines in the Philippines as outlined by the Department of Health. Test your knowledge on the administrative order and its implications for healthcare and pharmaceuticals in the country.

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