PAN AMERICAN NETWORK FOR DRUG REGULATORY HARMONIZATION

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PAN AMERICAN NETWORK FOR DRUG REGULATORY
HARMONIZATION
Mexico May, 2003 Steering Committee WG/GMP WG/D
Classification
Rosario DAlessio PAHO/WHO
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DRUG REGULATORY HARMONIZATION FORUMS

• International Conference on Drug Harmonization
  (ICH)
• European Agency on Drug Evaluation (EMEA)
• WHO International Conference of Drug Regulatory
  Authorities (ICDRA)
• Subregional Economic Groups
• MERCOSUR - CARICOM -
  AA
• NAFTA - CENTRAL AMERICA

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Groups of Economic Integrationin the Region of
the Americas
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HARMONIZATION
Search for common ground within the framework of
recognized standards, taking into account the
different political, health, and legislative
realities in the Americas Region
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I Pan American Conference on Drug Regulatory
Harmonization NOV 1997

• Priority to health consideration in trade and
  economic integration processes
• Support to ongoing harmonization process
• Strengthening of regulatory agencies
• Confidentiality of unpublished information
• Establishment of a hemispheric forum
• Secretariat PAHO
• Steering Committee
• All parties concerned with pharmaceuticals
• Financial support provided by industry and
  governments

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II Pan American Conference on Drug Regulatory
HarmonizationNOV 1999

• Advances in Drug Regulation
• Results from WGs on BE and GCP
• GMP key subject to be enforced
• Counterfeit drugs
• Drug classification
• Establishment of the Pan American Network for
  Drud Regulatory Harmonization

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III Pan American Conference on Drug Regulatory
HarmonizationAPRIL 2002

• Update on ICDRA, FTA, MERCOSUR, AA, CIECA in Drug
  Regulatory Harmonization
• Impact of ICH in ud countries
• WHO prequalification project
• Helsinky and Clinical Trials w/ active Controls
• Counterfeit drugs case study
• Promotion Sale of Drugs through Internet
• Group Report GMP BE GCP Counterfeit
  Farmacopoeia EQC
• Preliminary report on Regulatory Agencies Studies

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Pan American Network forDrug Regulatory
Harmonization
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PAN AMERICAN CONFERENCE ON DRH

• Objectives
• 1. To identify global harmonization issues and
  their relevance to the region
• 2. To identify the stage of development in the
  current sub-regional group
• 3. To identify common obstacles and/or problems
• 4. To recommend subjects, strategies and actions
  to facilitate hemispheric DRH.

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MISSION

CONFERENCE
STEERING COMMITTEE
The Conference should promote drug regulatory
harmonization for all aspects of quality, safety
and efficacy of pharmaceutical products as a
contribution to the quality of life and health
care of the citizens of the Member Countries of
the Americas.
The Steering Committee should enable progress
between Conferences by coordinating, promoting,
facilitating and monitoring harmonization
processes in the Americas.
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GOALS

Conference
Steering Committee

• To examine regulatory systems
• To develop and adopt proposals for technical
  regulatory harmonization
• To review existing regulatory requirements and
  guidelines for specific issues
• To identify and discuss medicinal regulation
  implementation issues

• Identify experts to ensure effectiveness and
  relevance of the conference
• To develop/maintain an information system to
  disseminate advancements on harmonization
• To identify mechanisms for fostering capacity
  building and technical scientific cooperation
• To provide information on regulatory systems

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OBJECTIVES

Conference
Steering Committee

• Dialogue among participants at the
  conferences
• Adopt recommendations
• Encourage convergence of drug regulatory
  systems
• Encourage and facilitate technical
  cooperation
• Promote harmonization

• Ensure effectiveness and relevance of the
  conference
• Monitor implementation of conference
• recommendations
• Ensure continuity
• Facilitate consensus - building and resolution
  of issues

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OPERATION

CONFERENCE
STEERING COMMITTEE
1. To organize meetings, workshops, to carry out
recommendations of the Conference. 2.To establish
study groups on regulatory topics identified by
the Conference as more relevant. 3. To determine
preparatory activities necessary for subsequent
Conferences. 4.To determine the best methods to
resolve issues and reach consensus. 5. To convene
meetings at which a quorum of two thirds of the
membership are present.
1.To promote participation by all interested
parties in the Americas and those invited by the
S C. 2.To be held every two years at a
date and place determined by the Steering
Committee. 3.To adopt all Conference
recommendations and conclusions by consensus in
plenary sessions. If consensus can not be
reached, the different points of view will be
recorded.
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FINANCING SOURCES

• Pharmaceutical Industry Associations
• Professional Associations
• Governments
• Conference Registration Fees
• Non Governmental Organizations
• Pan American Health Organization
• others

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SECRETARIAT

• 1. The Secretariat of the Network, the Conference
  and the Steering Committee will be provided by
  PAHO
• 2. The Secretariat shall
• Provide administrative and technical support
• Coordinate actions deriving from recommendations
  
• Act as a clearinghouse for information
• Arrange for expert advice and consultants
• Act asliaison, with similar programs such as
  ICDRA, ICH and other national or regional trade
  agencies, and others as necessary,
• Maintain permanent communication will the SC
• Seek financial support

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Steering Committee2002-2004

• 5 Regulatory Authorities
• Members Alternate
• Mexico USA
• Guatemala Costa Rica
• Jamaica Trinidad Tobago
• Brazil Argentina
• Colombia Bolivia
• One rep from FIFARMA -------------
• One rep from ALIFAR -------------
• NGOs related to pharmaceuticals in official
  relations with PAHO can participate as OBSERVERS
  at SC meetings

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Pan American Network for DRH

Working Groups
1. Good Manufacturing Practices 2. Bioequivalence
and Bioavailability 3. Good Clinical
Practices 4. Classification of Products 5.
Counterfeit Drugs 6. Pharmacopoeia 7.
Medicinal Plants 8. Farmacovigilance 9. Drug
Registration
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FROM THE III PAN CONF (May 2002- May 2003)

• III Pan American Conference
• GMP National Seminars
• Conclusion of Special Studies on DRA
• WEB page
• WG/GCP Meeting
• WG/BE
• Regional TRM WG/Medicinal Plants
• WG/ GMp, D Class SC

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FROM NOW UNTIL THE IV PAN CONFERENCE

• Two (or 3) set of meetings for all WGs

• ONE SC meeting to review WG development
  agenda for the IV Conference

• Educational Seminars
• Two GCP
• Two BE
• Six GMP