midterms - labeling

• Article III, Section 7 of the 1987 Philippine Constitution declares that the State recognizes the right of the people to gain information on matters of public concern, such as those relating to health and health products
• Labels and labeling materials are the primary sources of information for consumers. They provide useful information such as those dealing with the safe and effective use of a drug product (e.g. indication(s), pharmacologic class and dosage), and information dealing with quality (e.g. manufacturing and expiration dates, registration number, and manufacturer)
• The Food and Drug Administration (FDA), as the regulatory authority of the Philippines responsible for all matters pertaining to drug products, has issued several guidelines to ensure that drug establishments provide the most accurate information relating to their products
• In the course of the enforcement of these issuances, coupled with the advent of globalization and development of harmonization schemes of technical procedures and requirements applicable to the drug industry in the ASEAN region, gaps in regulations have been identified, and the need for a more transparent and clear regulatory guideline pertaining to labels has been raised
• This Administrative Order is issued to rationalize the regulations on labeling of drug products for human use, as well as to address the gaps and issues raised for the effective implementation of the declared policy
• The objective of this Administrative Order is to rationalize the existing rules and regulations on generic labeling requirements of drug products, consistent with the harmonized requirements of the ASEAN Member States; thus providing an updated and comprehensive guideline
• This Administrative Order shall apply to all manufacturers and distributors (i.e. exporters, importers and wholesalers) of drug products for human use, including herbal medicines and traditionally-used herbal products
• Definitions


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


  The molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative, responsible for the physiological or pharmacological action of the drug substance
• Active Pharmaceutical Ingredient (API)

  A substance or compound intended to be used in the manufacture of a pharmaceutical product as a therapeutically active compound
• Adverse Drug Reaction (ADR)

  A response to a medicine that is noxious and unintended, occurring at doses normally used in man
• Batch


  A defined quantity of starting material, packaging material, or product manufactured in a single or series of processes so that it can be expected to be homogeneous
• Batch Number


  A distinctive combination of numbers and/or letters specifically identifying a batch on labels, batch records, certificates of analysis, etc.
• Biological Product


  Any product of biological origin, prepared with biological processes, derived from human blood and plasma, or manufactured by biotechnology, consisting of substances of higher molecular weight whose purity, potency, and composition cannot be easily characterized
• Biological Product


  • Products of biological origin, prepared with biological processes, derived from human blood and plasma, or manufactured by biotechnology, consisting of substances of higher molecular weight whose purity, potency, and composition cannot readily and reliably be determined by chemical or physicochemical analysis
• Examples of Biological Products

  • Vaccines
  • Blood products
  • Modified animal tissues
  • High molecular weight hormones
  • Allergens
  • Products of genetic engineering or other newer biotechnological techniques
• Biological Products definition excludes antibiotics and substances of low molecular weight that can be isolated as pure substances, such as purified steroids and alkaloids
• Brand Name is the proprietary name assigned to the product by the Marketing Authorization Holder (MAH)
• Contraindication is a statement regarding the conditions wherein the use of the drug product may cause harm to the patient
• Date of Manufacture refers to the date (month and year) during which processing of the bulk product, from which the goods are to be filled, is completed
• Dosage is the quantity of a medicine given per administration
• Dosage Form is the drug product type (e.g. tablet, capsule, solution, cream) that contains a drug substance generally, but not necessarily, in association with excipient(s)
• Dosage Strength may refer to the concentration of the known API or active moiety in a given formulation stated in metric units or the potency of the known API or active moiety expressed in terms of units by reference to a standard
• Drug Product or Drug includes articles recognized in official pharmacopoeias, articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, articles intended to affect the structure or function of the human body or animals, articles intended for use as components of other articles, and herbal and traditional drugs
• Excipient


  An ingredient intentionally added to the drug substance which should not have pharmacological properties in the quantity used
• Expiration Date is the date placed on the label of a drug product designating the time prior to which a batch of the product is expected to remain within the approved shelf life specification if stored under defined conditions
• Expiration Date


  • The date (i.e. month and year) placed on the label of a drug product designating the time prior to which a batch of the product is expected to remain within the approved shelf life specification if stored under defined conditions
  • After the expiration date, there is no guarantee that the product will remain within the approved specifications and, therefore, it may be unsuitable for use and should not be used
• Formulation


  The name, strength, and reference monograph of all APIs and/or excipients present in the drug product
• Generic Class Name


  The identification of a drug product containing three or more APIs by its scientifically and internationally recognized name or by its official generic name as determined by FDA
• Generic Name


  The identification of a drug product by its scientifically and internationally recognized API or by its official generic name as determined by FDA
• Indication


  The FDA-approved clinical use of a drug product based on substantial, scientifically supported evidence of its safety and efficacy in the given dosage form
• Investigational Product


  A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use
• Label


  The written, printed or graphic matter on any drug product, its immediate container, tag, literature or other suitable material affixed thereto for the purpose of giving information as to the identity, components, ingredients, attributes, directions for use, specifications and such other information as may be required by law or regulation
• Labeling Materials


  Label on the immediate container, and the other printed materials that are made available with the drug product at the time of purchase and/or when the product is used, such as the outer wrapper cartons, package insert/leaflet accompanying the product, which provide the accurate and necessary detailed information for the identification and proper use of the product
• Lot Number


  Any distinctive combination of letters and/or numbers assigned to a particular lot, herein defined as a portion of a batch
• Manufacturer


  An establishment engaged in any and all operations involved in the production of health products as well as the final release of the finished product, with the end view of its storage, sale or distribution; provided, that the term shall not apply to the compounding and filling of prescriptions in drugstores and hospital pharmacies
• Marketing Authorization (MA)


  An official document issued by the competent drug regulatory authority (DRA) for the purpose of marketing or free distribution of a product after evaluation for safety, efficacy, and quality, and containing, inter alia: the name of the product; the pharmaceutical dosage form; the quantitative formula (including excipients) per unit dose; the shelf-life and storage condition(s); and packaging characteristics, specific information on which authorization is based (e.g. "The product(s) must conform with all the details provided in the application and as modified in subsequent correspondence."), the product information approved for health professionals and the public, the sales category, the name and address of the holder of the authorization, and the period of validity of the authorization. In the Philippines, the MA is in the form of a Certificate of Product Registration (CPR)
• Marketing Authorization Holder (MAH)


  The company or corporate or legal entity in the field of pharmaceuticals in whose name the MA for a drug product has been granted. This party is responsible for all aspects of the product, including quality and compliance with the conditions of the MA. The authorized holder must be subjected to legislation in the country that
• Marketing Authorization Holder (MAH)


  Any corporate or legal entity in the field of pharmaceuticals in whose name the MA for a drug product has been granted. Responsible for all aspects of the product, including quality and compliance with the conditions of the MA
• The authorized holder must be subjected to legislation in the country that issued the MA, which normally means being physically located in that country. In the Philippines, the MAH may either be a manufacturer or distributor (exporter, importer or wholesaler)