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Draft Administrative Order Specific Policies Governing Brand Names - - PowerPoint PPT Presentation

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Republic of the Philippines Department of Health Food and Drug Administration Draft Administrative Order Specific Policies Governing Brand Names of Pharmaceutical Products Food and Drug Administration Pharmaceutical Associations 22 May 2014

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Republic of the Philippines Department of Health Food and Drug Administration

Draft Administrative Order

Specific Policies Governing Brand Names of Pharmaceutical Products

Food and Drug Administration Pharmaceutical Associations

22 May 2014 Conference Room, 2nd Flr FDA Main Building

1

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Discussion Flow

I. Background II. Objectives

  • III. Scope
  • IV. General Guidelines

V. Requirements for a Brand Name

  • VI. Transitory Provisions
  • VII. Discussion

Center for Drug Regulation and Research 2

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Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 3

BACKGROUND

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Background

Part of the registration process – evaluation and approval of brand names to implement misbranding provisions of RA 3720 However – issues have been raised

Center for Drug Regulation and Research 4

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Background

Center for Drug Regulation and Research 5

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Background

Center for Drug Regulation and Research 6

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Center for Drug Regulation and Research 7

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Background

AO No. 131 s. 1970: Regulation Part C-3.2: Drugs: Prohibition of Use of More Than One Name for a Given Formulation

Center for Drug Regulation and Research 8

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Background

AO No. 131 s. 1970: Regulation Part C-3.2: Drugs: Prohibition of Use of More Than One Name for a Given Formulation

Center for Drug Regulation and Research 9

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Background

AO No. 38 s. 1979: Restriction on the Use of Several Brand Names for a Formulation of a Drug or Pharmaceutical Specialty

Center for Drug Regulation and Research 10

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Background

AO No. 38 s. 1979: Restriction on the Use of Several Brand Names for a Formulation of a Drug or Pharmaceutical Specialty

Center for Drug Regulation and Research 11

Amended by AO 42 s. 1979

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Background

AO No. 42 s. 1979

Center for Drug Regulation and Research 12

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Background

AO No. 42 s. 1979

Center for Drug Regulation and Research 13

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Background

AO No. 76 s. 1984: Guidelines to be Observed by FDA in Clearance of Name Relative to Food, Drugs, and Cosmetics

Center for Drug Regulation and Research 14

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Background

AO No. 76 s. 1984: Guidelines to be Observed by FDA in Clearance of Name Relative to Food, Drugs, and Cosmetics

Center for Drug Regulation and Research 15

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Background

AO No. 76 s. 1984: Guidelines to be Observed by FDA in Clearance of Name Relative to Food, Drugs, and Cosmetics

Center for Drug Regulation and Research 16

Revoked by AO No. 2006-0016

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Background

MC No. 10-a s. 1992: Registration of Branded Version of Registered Unbranded Generic Drug Product, and Generic Version of Unregistered Branded Drug Products

Center for Drug Regulation and Research 17

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Background

MC No. 10-a s. 1992: Registration of Branded Version of Registered Unbranded Generic Drug Product, and Generic Version of Unregistered Branded Drug Products

Center for Drug Regulation and Research 18

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Background

MC No. 10-a s. 1992: Registration of Branded Version of Registered Unbranded Generic Drug Product, and Generic Version of Unregistered Branded Drug Products

Center for Drug Regulation and Research 19

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Background

MC No. 16-A s. 1994: Limiting the Number of Proposed Brand Name for Brand Name Clearance for a Single Drug Product or Pharmaceutical Specialty

Center for Drug Regulation and Research 20

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Background

BC No. 21 s. 1999: Guidelines for the Evaluation of Brand Names for Products to be Registered with the Bureau of Food and Drugs

Center for Drug Regulation and Research 21

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Background

BC No. 21 s. 1999: Guidelines for the Evaluation of Brand Names for Products to be Registered with the Bureau of Food and Drugs

Center for Drug Regulation and Research 22

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Background

BC No. 21 s. 1999: Guidelines for the Evaluation of Brand Names for Products to be Registered with the Bureau of Food and Drugs

Center for Drug Regulation and Research 23

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Background

BC No. 21 s. 1999: Guidelines for the Evaluation of Brand Names for Products to be Registered with the Bureau of Food and Drugs

Center for Drug Regulation and Research 24

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Background

BC No. 21 s. 1999: Guidelines for the Evaluation of Brand Names for Products to be Registered with the Bureau of Food and Drugs

Center for Drug Regulation and Research 25

Revoked by AO No. 2006-0016

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Background

BC No. 22 s. 1999: Deletion of the Requirement for a Certificate of Brand Name Clearance in Filing an Application for Registration of Branded Products

Center for Drug Regulation and Research 26

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Background

AO No. 2005-0016: General Policies and Guidelines Governing Brand Names of Products for Registration with the Bureau of Food and Drugs

Center for Drug Regulation and Research 27

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Background

AO No. 2005-0016: General Policies and Guidelines Governing Brand Names of Products for Registration with the Bureau of Food and Drugs

Center for Drug Regulation and Research 28

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Background

AO No. 2005-0016: General Policies and Guidelines Governing Brand Names of Products for Registration with the Bureau of Food and Drugs

Center for Drug Regulation and Research 29

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Background

PSD Memo 07-2005: Procedure for the Submission of Proposed Brand Names

Center for Drug Regulation and Research 30

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Approach

Creation of a specific guideline/policy for brand name of drug products Adopt previous guidelines/policies which may still be applicable

Center for Drug Regulation and Research 31

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Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 32

OBJECTIVES

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Objectives

promote the rational use of drugs prevent medication errors and potential harm to the public by setting specific policies and guidelines for the evaluation and approval of brand names

Center for Drug Regulation and Research 33

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Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 34

SCOPE

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Scope

all manufacturers, traders and distributors (e.g. exporters, importers and wholesalers) of pharmaceutical products

Center for Drug Regulation and Research 35

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Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 36

GENERAL GUIDELINES

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General Guidelines

  • A. specific pharmaceutical product

formulation may be marketed by its MAH under its generic name or together with its brand name

  • B. a MAH shall be allowed to register an

unbranded counterpart – both subject to initial registration

Center for Drug Regulation and Research 37

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General Guidelines

  • C. Any name may be accepted as the brand

name – meets the requirements

  • D. FDA reserves the right to disapprove brand

names

Center for Drug Regulation and Research 38

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Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 39

REQUIREMENTS FOR A BRAND NAME

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AO No. 2005-0016

Not allowed: 1) identical to those already registered with FDA 2) offensive, obscene, scandalous, or

  • therwise contrary to public morals and

policy

Center for Drug Regulation and Research 40

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Additional Requirements

  • A. Deceptively descriptive brand names;
  • B. Refer to a specific person, place, or event

that which may give false impressions about the product;

Center for Drug Regulation and Research 41

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Additional Requirements

  • C. Confusing:

1) In speech, in rhyme or in writing (sound alike, look alike names); 2) Similar or identical with the first and/or last syllables of another brand name, unless other syllables create a distinctive appearance or sound; they must be different either in prefix, middle or suffix syllables if applied to different generic class of drug or where the drugs have different indications;

Center for Drug Regulation and Research 42

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Additional Requirements

  • C. Confusing:

3) Use of a single brand name for a wide range

  • f pharmaceutical formulation by a single
  • MAH. This is allowed if a qualifier (e.g., XY-

100, XY-300; XY, XY-Forte;)is included 4) a brand name similar to an INN that is not its generic name (e.g., Mefen for Ibuprofen)

Center for Drug Regulation and Research 43

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Additional Requirements

identical nor similar to the World Health Organization (WHO) List of Recommended and Proposed INN, United States Approved Name (USAN), Compendial Name, or any

  • ther well established chemical names

Center for Drug Regulation and Research 44

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Similarity to INNs

Changing or dropping a single letter or syllable from the INN (e.g., Paracetam for Paracetamol); Inclusion of INN stems, as provided under WHO List of Common Stems (e.g., Laracillin,

  • cillin is an INN stem); and

Combining INN elements for a multi- component product (e.g., Sulfaprim for Sulfadoxine and trimethoprim).

Center for Drug Regulation and Research 45

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Similarity to INNs

Any revisions and supplements to the WHO List of Recommended and Proposed INN, and List of Common Stems shall be automatically adopted

Center for Drug Regulation and Research 46

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Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 47

TRANSITORY PROVISIONS

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Transitory Provisions

shall apply 1 year after effectivity all previously cleared brand names that may be contrary to the provisions of this AO, clearance for the respective brand names shall be secured upon submission of MAHs

  • f their applications for renewal registration

Center for Drug Regulation and Research 48

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Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 49

DISCUSSION