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 Administration Pharmaceutical Associations 22 May 2014 Conference Room, 2nd Flr FDA Main Building 1
Discussion Flow I. Background II. Objective III. Scope IV. General Requirements V. Specific Requirements Center for Drug Regulation and Research 2
Discussion Flow VI. Mandatory Information for Labelling Materials VII. Special Labelling Instructions VIII. Exemptions IX. Transitory Provisions X. Discussion Center for Drug Regulation and Research 3
Republic of the Philippines Department of Health Food and Drug Administration BACKGROUND Center for Drug Regulation and Research 4
Full adoption of ACTD/ACTR Center for Drug Regulation and Research 5
Center for Drug Regulation and Research 6
Other triggers Gaps in the current regulations raised Harmonization of labeling requirements to some extent Center for Drug Regulation and Research 7
Existing Regulations Administrative Order No. 61 s. 1968 Center for Drug Regulation and Research 8
Existing Regulations Administrative Order No. 109 s. 1969 Center for Drug Regulation and Research 9
Existing Regulations Administrative Order No. 126 s. 1970 Center for Drug Regulation and Research 10
Existing Regulations Administrative Order No. 55 s. 1988 Center for Drug Regulation and Research 11
Existing Regulations Administrative Order No. 64 s. 1989 Center for Drug Regulation and Research 12
Existing Regulations Administrative Order No. 85 s. 1990 Center for Drug Regulation and Research 13
Existing Regulations Administrative Order No. 99 s. 1990 Center for Drug Regulation and Research 14
Existing Regulations Memorandum Circular No. 6 s. 1991 Center for Drug Regulation and Research 15
Existing Regulations Memorandum Circular No. 11 s. 1991 Center for Drug Regulation and Research 16
Republic of the Philippines Department of Health Food and Drug Administration Draft Administrative Order OBJECTIVE Center for Drug Regulation and Research 17
Objective 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 Center for Drug Regulation and Research 18
Republic of the Philippines Department of Health Food and Drug Administration Draft Administrative Order SCOPE Center for Drug Regulation and Research 19
Scope all manufacturers, traders and distributors (i.e. exporters, importers and wholesalers) of pharmaceutical products for human use, including herbal and traditional med Center for Drug Regulation and Research 20
Republic of the Philippines Department of Health Food and Drug Administration Draft Administrative Order GENERAL REQUIREMENTS Center for Drug Regulation and Research 21
General Requirements 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 Center for Drug Regulation and Research 22
General Requirements 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 Center for Drug Regulation and Research 23
General Requirements 1) English and/or Filipino 2) Readable with normal vision without straining 3) Color contrast, position, and spacing must be considered Center for Drug Regulation and Research 24
General Requirements 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 Center for Drug Regulation and Research 25
Republic of the Philippines Department of Health Food and Drug Administration Draft Administrative Order SPECIFIC REQUIREMENTS Center for Drug Regulation and Research 26
Product Name 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 Center for Drug Regulation and Research 27
Product Name 6) Multiple APIs - all APIs shall be indicated, in order of decreasing pharmacological activity, of decreasing potency; provided that if single 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 Center for Drug Regulation and Research 28
Product Name 6) Multiple APIs: A B Center for Drug Regulation and Research 29
Dosage Form and Strength 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 vs. rectal) if any and appropriate are required d) No qualifier for tablets – oral, uncoated, IR tablet Center for Drug Regulation and Research 30
Dosage Form and Strength 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 Center for Drug Regulation and Research 31
Dosage Form and Strength 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 Center for Drug Regulation and Research 32
Dosage Form and Strength Center for Drug Regulation and Research 33
Pharmacologic Category As determined by FDA Center for Drug Regulation and Research 34
Formulation/Composition 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 Center for Drug Regulation and Research 35
Formulation/Composition Center for Drug Regulation and Research 36
Formulation/Composition 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 Center for Drug Regulation and Research 37
Indication 1) Only FDA approved clinical use Center for Drug Regulation and Research 38
Dosage and Mode of Administration 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 Center for Drug Regulation and Research 39
Dosage and Mode of Administration 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 Center for Drug Regulation and Research 40
Contraindication(s), Precaution(s), Warning(s) 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 occasion only, “ single use only ”, “ single dose ” Center for Drug Regulation and Research 41
Interactions 1) Drug-Drug 2) Drug-Food 3) Drug-Laboratory test 4) Other relevant Center for Drug Regulation and Research 42
Overdose and Treatment 1) Signs and Symptoms of Overdose 2) Treatment for overdose Center for Drug Regulation and Research 43
Storage Condition 1) Appropriate storage conditions and special instructions for handling (e.g. cold chain) 2) Special labelling instructions: Center for Drug Regulation and Research 44
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