Republic of the Philippines Department of Health Food and Drug ... Name... · last syllables of...
Transcript of Republic of the Philippines Department of Health Food and Drug ... Name... · last syllables of...
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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
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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
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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
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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
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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
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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
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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
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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 otherwise contrary to public morals and policy
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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;
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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;
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Additional Requirements C. Confusing:
3) Use of a single brand name for a wide range of 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)
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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 other well established chemical names
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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).
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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
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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 of 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