IV Pan American Conference on Drug Regulatory Harmonization Dominican Republic 24 March 2005

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IV Pan American Conference on Drug Regulatory
Harmonization Dominican Republic2-4 March 2005

• Report of the Bioequivalence
• Working Group
• Justina A. Molzon
• CDER/U.S. FDA

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Report of the BioequivalenceWorking Group

• Background
• Meetings
• Activities
• Accomplishments
• Proposal
• Mission and objectives
• Request
• National Drug Regulatory Authorities
• BE Working Group

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PANDRH Steering Committee Priorities

• Urgent Issues
• GMP (FDA)
• BA/BE (FDA)
• GCP (ANMAT)
• Counterfeit (ANVISA)

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Work plan of Working Group

• Assessment of BE in countries
• Selection of team members
• Working group meeting
• Regulatory needs survey
• Selection of training materials
• Regional seminars

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BE Working Group Current Members

• Contact Person Justina Molzon (FDA)
• Topic Lead Lizzie Sanchez (FDA)
• ALIFAR Silvia Giarcovich
• Argentina Ricardo Bolaños
• Brazil Silvia Storpitis
• Canada Conrad Pereira
• Chile Regina Pezoa
• Costa Rica Lidiette Fonseca
• FIFARMA Loreta Marquez
• Jamaica Eugenie Brown
• Venezuela Mara de Levy/Irene Goncalves
• USP Roger Williams
• University of Texas Salomon Stavchansky

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BE Working Group Meetings

• September 14, 2000Washington, DC
• III Conference April 24-26, 2002
• December 3-4, 2002Caracas, Venezuela
• February 14-15, 2003Brasilia, Brazil
• August 11-12, 2003Mexico City, Mexico
• April 28-30 April, 2004Antigua, Guatemala

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1st Meeting of theBioequivalence Working Group

• Focused on selection of training topics
• Developed a modular training program
• Determined resource materials to support the
  training modules
• Materials translated into Spanish

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(No Transcript)
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2nd Meeting of theBioequivalence Working Group

• Topics for Discussion
• Criteria for prioritizing BE studies in countries
  where they are currently not being conducted
• Criteria for selecting BE drug comparator
• Indicators to be used by the WG/BE to follow up
  the implementation of BE in the Americas

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3rd Meeting of theBioequivalence Working
Group

• Reviewed Recommendations from PANDRH III
• Defined the groups MISSION
• The working group should contribute to harmonized
  bioequivalence criteria for the
  interchangeability of pharmaceutical products in
  the Americas
• Prioritized objectives

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Prioritized Objectives

• 1. Develop science based criteria for products
  requiring in vitro and/or in vivo BE studies and
  those not requiring BE studies
• 2. Develop prioritized lists (core
  nucleus/recommended) of those pharmaceutical
  products where in vivo BE studies are necessary
  
• 3. Develop a list of pharmaceutical products
  where in vivo BE studies are not necessary
• 4. Develop a list of comparator drug products for
  use in the Americas region

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4th Meeting of the Bioequivalence Working Group

• Listed science based criteria for products
  requiring in vitro and/or in vivo BE studies and
  those not requiring BE
• Developed prioritized list of pharmaceutical
  products where in vivo BE studies are necessary

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WG Activities

• BE Study
• Questionnaire was distributed
• Responses
• 9 (50) from Spanish speaking countries
• 2 from English speaking countries
• Remaining countries encouraged to provide
  requested information

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WG Activities

• Consolidated document on criteria for BE studies
• List of priority products
• Members in process of reviewing the documents for
  next meeting
• Comments to be incorporated into the document

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WG Activities

• Regional Comparator
• Subgroup met January 12, 2004 and advanced the
  discussion of the subject
• Three documents developed
• ALIFAR opinion on the topic
• Statement of Reference Product (USP)
• Product of reference situational analysis
  (FIFARMA)
• WG members sent documents for review

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5th Meeting of the Bioequivalence Working Group

• Group reviewed consolidated documents
• Science based criteria for products requiring in
  vitro and/or in vivo BE studies and those not
  requiring BE studies
• Strategy for countries to harmonize the list of
  products requiring BE studies
• Title changed to Science based criteria for
  bioequivalence testing and bio-waivers AND
  strategic framework for implementation

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Proposals and Requests

• BE WG study
• Mission
• Objectives
• Requests
• National Drug Regulatory Authorities
• BE Working Group

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Proposal

• Taking into account the previous comments, the
  interest demonstrated by the countries in the
  implementation of BE studies as a strategy to
  promote the interchangeability of products and
  promote policies of access to quality drugs, the
  BE WG requests the following

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ProposalBE Study Mission

• Take note of the BE study developed by the
  Working Group
• Approve the WGs Mission
• The working group should contribute to
  harmonized bioequivalence criteria for the
  interchangeability of pharmaceutical products in
  the America

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ProposalPrioritized Objectives

• 1. Develop science based criteria for products
  requiring in vitro and/or in vivo BE studies and
  those not requiring BE studies
• 2. Develop prioritized lists (core
  nucleus/recommended) of those pharmaceutical
  products where in vivo BE studies are necessary
  
• 3. Develop a list of pharmaceutical products
  where in vivo BE studies are not necessary
• 4. Develop a list of comparator drug products for
  use in the Americas region

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Proposal-Objectives

• 5.Develop recommendations and guidelines for the
  interpretation, evaluation and application of
  science based bioequivalence principles.
• 6.Promote and assist in education and training in
  countries of the Americas to implement
  bioequivalence principles

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Proposal-Objectives

• 7.Promote bioequivalence of pharmaceutical
  products in the countries of the Americas
• 8.Adjust training programs to share regulatory
  experience in implementing BE within the
  framework of the PANDRH
• 9.Develop indicators to evaluate implementation
  of BE in the Americas

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Proposal-Draft Document

• To note the DRAFT document
• Science Based Criteria for bioequivalence testing
  (in vitro and in vivo), bio-waivers, and the
  strategic framework for its implementation

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Request National Drug Regulatory Authorities

• 1. To note the Draft Document
• 2. To promote the harmonization of active
  ingredients list for those requiring proof of BE,
  utilizing as a reference the strategy presented
  by the BE WG based on health risk criteria and
  the specific realities observed in each country

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Request National Drug Regulatory Authorities

• 3. To develop a training program in BE for its
  human resources and to promote the participation
  of the appropriate personnel in educational
  activities on BE carried out by the PANDRH

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PARF Network and WG/BE

• 1. To request WG/BE to complete the DRAFT
  document and to ensure that a FINAL version of
  the document is presented at the next (V) Pan
  American Conference on Drug Regulatory
  Harmonization
• 2. To request the WG/BE to prepare a progress
  report on the implementation of BE studies in the
  Americas, to be presented at the next Conference

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Muchas graciasMuito obrigadaMerci

• Thank you