definition of terms ra 9711, ra 3720, and irr or ra 9711

• 'FDA' stands for the Food and Drug Administration
• 'Food' refers to any processed substance intended for human consumption, including drinks, beverages, chewing gum, and substances used in the manufacture, preparation, or treatment of food
• 'Drug' includes articles recognized in official pharmacopeias, articles intended for disease diagnosis, cure, mitigation, treatment, or prevention, articles intended to affect the body's structure or function, and articles intended as components of specified articles but excludes devices
• 'Device' encompasses medical devices, radiation devices, and health-related devices
• 'Medical device' includes instruments, apparatus, machines, implants, in-vitro reagents, or calibrators intended for diagnosis, prevention, monitoring, treatment, or alleviation of disease
• 'Radiation device' emits ionizing or non-ionizing radiation, while 'health-related device' adversely affects people's health
• 'Cosmetics' are substances intended for external human body parts or oral cavity, for cleaning, perfuming, appearance change, body odor correction, or protection
• 'Label' is a display of written, printed, or graphic matter on the immediate container of an article
• 'Director-General' is the head of the FDA
• 'Distribute' means the delivery or sale of any health product for distribution in commerce, excluding manufacturing or retailing
• 'Manufacturer' refers to establishments engaged in health product production operations
• 'Veterinary drugs' are drugs intended for animal use, excluding animal feeds
• 'Assay' is an analysis to determine substance presence, amount, or pharmaceutical potency
• 'Authorization' is a permission granted by the FDA for various health product activities
• 'Bioavailability' is the rate and extent of active ingredient absorption from a drug
• 'Bioequivalence' refers to the rate and extent of drug absorption compared to a listed drug under similar conditions
• 'Distributor/Importer/Exporter' imports or exports raw materials, active ingredients, or finished products
• 'Distributor/Wholesaler' procures health products for local distribution on a wholesale basis
• 'Establishment' includes entities engaged in health product activities
• 'Food/Dietary supplement' is a processed food product intended to supplement the diet
• 'Health products' encompass food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents, and household/urban hazardous substances
• 'Household/Urban hazardous substance' includes toxic, corrosive, or flammable substances intended for limited purposes
• 'In-vitro diagnostic reagents' are for disease diagnosis or health state determination
• 'Licensing' is the approval process for operating health product-related establishments
• 'Misbranding' refers to misinformation on health product labels authorized by the FDA
• 'Registration' is the approval process for registering health products prior to engaging in related activities
• 'Trader' is an establishment owning health products and engaging in their distribution or marketing
• 'Retailer' sells health products directly to the general public
• Distributor/Importer/Exporter:

  • Imports or exports raw materials, active ingredients, and/or finished products for own use or wholesale distribution
  • If sells to the general public, considered a retailer
• Distributor/Wholesaler:

  • Procures raw materials, active ingredients, and/or finished products from a local establishment for local distribution on a wholesale basis
• Drug:

  • Articles recognized in official pharmacopoeias and formularies
  • Intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals
  • Intended to affect the structure or function of the body
  • Intended as a component of specified articles but not devices or their components, parts, or accessories
• Establishment:

  • Engaged in the manufacturer, importation, exportation, sale, distribution, donation, transfer, use, testing, promotion, advertising, or sponsorship of health products
  • Includes facilities and installations needed for activities
• FDA:

  • Food and Drug Administration created under Republic Act No. 9711
• FDA Act of 2009:

  • Refers to Republic Act No. 9711, known as the Food and Drug Administration Act of 2009
• Fees:

  • Include licensing, accreditation, registration charges, and other related regulatory fees
  • Fees from sale of publications and services, assessment fees, fines, penalties, and other charges
• Food:

  • Any processed substance intended for human consumption
  • Includes drinks, chewing gum, and substances used in food preparation
• Food/Dietary Supplement:

  • Processed food product intended to supplement the diet
  • Contains dietary ingredients like vitamins, minerals, amino acids, herbs
  • Intended to increase daily intake according to recommended energy and nutrient intakes
• Foods, Drugs and Devices, and Cosmetics Act:

  • Refers to Republic Act No. 3720, as amended by Executive Order 175 and FDA Act of 2009
• Health products:

  • Include food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents, household/urban hazardous substances
  • Products that may have an effect on health requiring FDA regulations
• Health Product vigilance:

  • Science and activities related to detecting, assessing, understanding, and preventing adverse effects from health products