Draft Administrative Order Revised Rules and Regulations Governing - - PowerPoint PPT Presentation
Republic of the Philippines Department of Health Food and Drug Administration Draft Administrative Order Revised Rules and Regulations Governing the Generic Labelling Requirements of Pharmaceutical Products for Human Use Food and Drug
Republic of the Philippines Department of Health Food and Drug Administration
Food and Drug Administration Pharmaceutical Associations
22 May 2014 Conference Room, 2nd Flr FDA Main Building
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Republic of the Philippines Department of Health Food and Drug Administration
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Gaps in the current regulations raised Harmonization of labeling requirements to some extent
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Administrative Order No. 61 s. 1968
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Administrative Order No. 109 s. 1969
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Administrative Order No. 126 s. 1970
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Administrative Order No. 55 s. 1988
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Administrative Order No. 64 s. 1989
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Administrative Order No. 85 s. 1990
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Administrative Order No. 99 s. 1990
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Memorandum Circular No. 6 s. 1991
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Memorandum Circular No. 11 s. 1991
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Republic of the Philippines Department of Health Food and Drug Administration
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Draft Administrative Order
rationalize the existing rules and regulations on generic labeling requirements of pharmaceutical products, consistent with the harmonized requirements of the ASEAN Member States; thus, providing a more updated and comprehensive guideline as a response to the needs of the pharmaceutical industry and the public
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Republic of the Philippines Department of Health Food and Drug Administration
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Draft Administrative Order
all manufacturers, traders and distributors (i.e. exporters, importers and wholesalers)
including herbal and traditional med
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Republic of the Philippines Department of Health Food and Drug Administration
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Draft Administrative Order
1) Product Name 2) Dosage Form and Strength 3) Pharmacologic Category 4) Formulation/Composition 5) Indication(s) 6) Dosage and Mode of Administration 7) Contraindication(s), Precaution(s), Warning(s) (if applicable) 8) Interactions 9) Overdose and Treatment
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10)Storage Condition(s) 11)Net Content or Pack Size 12)Name and Address of MAH 13)Name and Address of Manufacturer 14)Rx Symbol and Caution Statement 15)ADR Reporting Statement 16)Registration Number 17)Batch Number and Lot Number (if any) 18)Expiration Date and Date of Manufacture
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1) English and/or Filipino 2) Readable with normal vision without straining 3) Color contrast, position, and spacing must be considered
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1) NCEs, biotech products, and Rx generic products –PI; NCEs and biotech – PI must be based from SPC 2) HR, OTCs, Herbal, TM – PIL 3) In lieu of PI or PIL - printed directly on the reverse side or inner panel of the outer packaging material or inner carton; provided, that the product is intended to be sold or dispensed together with such packaging material or inner carton
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Republic of the Philippines Department of Health Food and Drug Administration
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Draft Administrative Order
1) Generic and brand name (if any) 2) Generic name shall be as the active moiety based in INN, consistent with the dosage strength indicated 3) Generic name shall appear prominently, enclosed in outline box 4) Herbal and TM: Botanical origin or as recognized by FDA 5) Generic name shall appear above brand name
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6) Multiple APIs - all APIs shall be indicated, in
approved name for FDC, single approved name shall be used; provided further if there is no single approved name but a generic class name exist, generic class name shall be used. The individual components shall be indicated under formulation
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6) Multiple APIs:
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1) Label shall specify: a) Dosage form (tablet vs capsule) b) Special delivery system (sustained- release vs. extended-release) c) Specific mode of administration (vaginal
required d) No qualifier for tablets – oral, uncoated, IR tablet
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2) dosage strength - expressed in metric units reduced to lowest terms and in the number of the largest unit specified (e.g. 500mcg, not 0.5mg) 3) strength of certain dosage forms to be expressed as percentage
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4) dosage strength of each API shall be stated in accordance with the arrangement of the APIs, separated by a slash sign (/); provided, that if a single approved INN of the combination drug is used, the dosage strength shall be indicated as the whole
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As determined by FDA
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1) Name and strength of all APIs present per unit dose of product in generic names, arranged in decreasing potency 2) Name of API shall be stated in full (including its salt or hydrate form, if any), in accordance with INN or FDA approved name 3) reference monograph finished product shall be indicated, unless non-official; for multiple API, it shall be indicated after the first API
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4) Alcohol must be expressed as percentage; alcohol without qualification - ethanol 5) Excipients that may cause hypersensitivity shall be indicated, and/or other adverse reactions shall also be indicated, with the amount expressed in the same manner as the API 6) Preservative/antimicrobial agents shall be indicated, with the amount expressed in the same manner as the API
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1) Only FDA approved clinical use
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1) Recommended dosage, where applicable: a) Initial/loading dose b) Optimal use or usual dose c) Frequency interval d) Duration of treatment e) Dosage adjustment
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2) Dilution/reconstitution/preparation instructions in all labeling materials; description of the reconstituted preparation; description of reconstituted solution is also required 3) Dosage for special populations, adults and children; if not for children, “adult dose” or any statement to that effect
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1) Full information on contraindication, as well as the precautions to be observed 2) Special warnings should be included as required and specified by FDA 3) For products are to be used on one
dose”
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1) Drug-Drug 2) Drug-Food 3) Drug-Laboratory test 4) Other relevant
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1) Signs and Symptoms of Overdose 2) Treatment for overdose
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1) Appropriate storage conditions and special instructions for handling (e.g. cold chain) 2) Special labelling instructions:
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1) Unit carton – pack size expressed in terms
each unit; for reconstitution products, the reconstituted volume
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10 Blister Packs x 10 Tablets 12 Sachets x 5g 60mL 12 vials x 5mL 100 Tablets
2) Primary label (except blisters and foil strips) – net content stating the total amount/quantity of dosage form in a given container
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100 Tablets 5g 60mL 5mL
Name and address of MAH
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Market Authorization Holder: Pavenus Ltd Mother Ignacia cor. Sgt. Esguerra St., Diliman Quezon City
Name and address of manufacturer below the MAH
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Market Authorization Holder: Pavenus Ltd Mother Ignacia cor. Sgt. Esguerra St., Diliman Quezon City Manufacturer: Will Del Una Intl
1) Required for prescription products a) Printed in contrasting color to the background b) Allowed to be over-printed or superimposed 2) Caution Statement – unit carton, primary label except blister pack, foil strip, and small containers, and package insert: Foods, Drugs, Devices, and Cosmetics Act prohibits dispensing without prescription.
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2) For Dangerous drugs, additional caution statement as specified by PDEA
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1) For the unit carton and primary label (except blister pack, foil strip, and small containers), the statement “For suspected adverse drug reaction, report at the FDA website: www.fda.gov.ph”
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1) Registration number assigned by FDA
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1) Batch number if marketed by one drug establishment 2) If divided into lots marketed by different establishments, lot and batch number
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1) Month and year is required, understood to be the last day of the month if no day specified; year is stated completely 2) For reconstituted products or can be administered multiple times, the label shall include the period of guaranteed safety and efficacy after first opening at a given storage condition
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Republic of the Philippines Department of Health Food and Drug Administration
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Draft Administrative Order
1) Product Name 2) Dosage Form and Strength 3) Pharmacologic Category 4) Formulation/Composition 5) Indication(s) 6) Warning(s) (if applicable) 7) Storage condition(s) 8) Pack Size
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9) Name and Address of MAH 10)Name and Address of Manufacturer 11)Rx Symbol and Caution Statement 12)ADR Reporting Statement 13)Registration Number 14)Batch Number and Lot Number (if any) 15)Expiration Date and Date of Manufacture
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1) Product Name 2) Dosage Form and Strength 3) Pharmacologic Category 4) Formulation/Composition 5) Indication(s) 6) Warning(s) (if applicable) 7) Storage condition(s) 8) Net Content
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9) Name and Address of MAH 10)Name and Address of Manufacturer 11)Rx Symbol and Caution Statement 12)ADR Reporting Statement 13)Registration Number 14)Batch Number and Lot Number (if any) 15)Expiration Date and Date of Manufacture
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1) Product name on each unit or every two (2) units for multiple APIs; 2) Dosage form and strength of API(s) on each unit or every (2) units for multiple APIs; provided, that if the pharmaceutical product is visible from its packaging, the dosage form may no longer be indicated; 3) Name and/or logo of the MAH on each unit or every two (2) units for multiple APIs (for unbranded products only)
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4) Rx symbol on each unit or every two (2) units for multiple APIs 5) Batch number and expiration date on every standard blister pack/foil strip
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1) Product name 2) Dosage Form and Strength 3) Warning(s) 4) Net Content 5) Name and/or Logo of MAH 6) Rx Symbol 7) Registration Number 8) Batch and/or Lot Number 9) Expiration date and Date of Manufacture
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1) Product Name 2) Dosage Form and Strength 3) Pharmacologic Category 4) Product Description 5) Formulation/Composition 6) Pharmacodynamics/Pharmacokinetics 7) Indication(s)
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8) Dosage and Mode/Route of Administration 9) Contraindication(s), Precaution(s), Warning(s) (if applicable) 10)Pregnancy and Lactation (if applicable) 11)Interactions 12)Undesirable Effects 13)Overdose and Treatment 14)Storage Condition(s)
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15)Dosage Forms and Packaging Available (pack size) 16)Instructions and Special Precautions for Handling and Disposal (if applicable) 17)Name and Address of Marketing Authorization Holder and Manufacturer 18)Caution Statement 19)ADR Reporting Statement 20)Registration Number 21)Date of First Authorization/Renewal of Authorization 22)Date of Revision of Package Insert
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1) Product Name 2) Strength of the Medicine (Dosage Strength) 3) Description of the Product (Product Description) 4) What is in the Medicine? (Formulation/Composition) 5) What is this Medicine used for? (Indication(s)) 6) How much and how often should you use this Medicine? (Dosage and Mode/Route of Administration)
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7) When should you not take this Medicine? (Contraindication(s), Warning(s), Pregnancy and Lactation) 8) Care that should be taken when taking this Medicine? (Precaution) 9) Undesirable Effects 10)What other medicine or food should be avoided whilst taking this Medicine? (Interactions with
11)What should you do if you miss a dose?
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12)Signs and Symptoms of Overdosage 13)What to do when you have taken more than the recommended dosage? 14)How should you keep this Medicine? (Storage condition(s)) 15)When should you consult your doctor? 16)Name and address of MAH 17)Registration Number 18)Date of Revision of PIL
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Republic of the Philippines Department of Health Food and Drug Administration
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Draft Administrative Order
1) All labeling materials: excipients and amounts shall appear in the formulation 2) Unit carton and primary label: a) recommended mode of administration such as “intravenous”, “intramuscular” or “subcutaneous” b) For concentrated solution – direction not to administer the solution undiluted and direction to dilute in the primary label
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c) Without antimicrobial agent/intended for single use only, the statement, “Use only
statement to that effect
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1) fluid replacement and dialysis solution products which follow standard formulations contained in
generic class name; 2) Non-official solutions – FDA shall determine generic class name 3) directly below the generic class name but still inside the generic outline box – individual components with corresponding mEq/L or mmol/L enumerated in the order of decreasing pharmacologic activity
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4) amino acids and/or proteins - total amount
in the container 5) Nominal osmolality and nominal pH range
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Rendered in all capital letters and red background or red font Ex.
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Multivitamin/Mineral/Herbal Products with Standard Formulations and Non- vitamin/mineral/herbal Components
1) Multivitamins and Minerals for multi-vitamin and multi-mineral-containing products 2) For these products with additional herbal ingredients (at least 3) – generic class name shall be herbs 3) For multi-vitamin products with individual non- vitamin components (i.e. mineral or herbal ingredient), or multi-mineral products with individual non-mineral components (vitamin or herbal ingredient), the term “Multivitamins” or “Minerals” shall first be stated, followed by additional individual components
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Multivitamin/Mineral/Herbal Products with Standard Formulations and Non- vitamin/mineral/herbal Components
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Multivitamin/Mineral/Herbal Products with Standard Formulations and Non- vitamin/mineral/herbal Components
4) content of each vitamin present shall no longer be required to be indicated in the generic box, but shall appear in the Formulation
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Drugs listed under Section 1 of E.O. No. 821:
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Republic of the Philippines Department of Health Food and Drug Administration
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Draft Administrative Order
1) Drug products manufactured for export; 2) Veterinary drug products; 3) The container or primary pack containing the product is enclosed in a transparent covering and the particulars which are required to be set on the label on the container or primary pack are clearly visible through transparent covering, the transparent covering is exempted; 4) Products that are compounded by a pharmacist in accordance with the individual prescription of a medical practitioner or dentist for immediate use;
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5) Investigational drugs, i.e. new chemical or structural modification of a tried and tested or established drug proposed to be used for a specific therapeutic indication(s); 6) Foreign donated pharmaceutical products; 7) Products that require special handling (pre-filled syringes, cold chain); and 8) Low volume of importation
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1) GLE application – submitted with registration application 2) Approval – GLE Certificate w/ validity and number 3) GLE Certificate Number and Registration Number
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Republic of the Philippines Department of Health Food and Drug Administration
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Draft Administrative Order
All registered pharmaceutical product shall be required to submit the revised labeling materials compliant with this Administrative Order upon renewal of their MA
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Republic of the Philippines Department of Health Food and Drug Administration
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