Pan American Network on Drug regulatory Harmonization WGMedicinal Plants

1
Pan American Network on Drug regulatory
HarmonizationWG/Medicinal Plants

• II Meeting
• 29-31, March
• Curitiba, Brazil

2
Background in the Americas I

• Regional Experts Meeting Jamaica (Nov 2000)
• Requirements for registration of MP
• Concept of MP

3
Regional Experts Meeting (2000)Participants

• Regulators from
• Bolivia, Colombia, Cuba, Chile, Ecuador,
  Guatemala, Jamaica, Peru USA
• Other participants
• Rep from MERCOSUR, Industry, WHO Collaborating
  Centers Research Institutes
• WHO and PAHO

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Regional Expert Meeting (2000)Confirmed

• There are various form of TRM in the context of
  different cultures without a parallel development
  of international standards and effective methods
  for evaluating traditional medicines.
• Regulation/registration for herbal products and
  traditional therapies are inadequate in most
  countries.
• Drug Regulators of the America have expressed to
  PAHO/WHO their interest to work in the area of HM
  to develop a harmonized proposal on process and
  requirements herbal product registration.

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Regional Experts Meeting (2000)Objectives

• To discuss issues surrounding production,
  registration and use of herbal products to
  develop a proposal on harmonized standards and
  regulations to assure safe, safety and quality of
  products.
• To analyze the main issues on national policy,
  economic issues and regulation and registration
  of herbal products to share the experience on
  regulation and registration of herbal products.
• To introduce WHO relative guidelines for
  assessment of safety and efficacy of herbal
  medicines.
• To discuss and adopt a proposal on common
  requirements of registration of herbal products.
• To facilitate integration of traditional medicine
  into national health care system.

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Regional Experts Meeting (2000)Outcomes

• A report on the situation on the use of herbal
  medicine and main issues concerning national
  policies, economic issues and regulation and
  registration of herbal product in selected
  countries,
• A proposal on common requirements will be
  adopted, and
• A proposed plan of action to follow up
  conclusions and recommendations of the meeting.

• A report on the situation on the use of herbal
  medicine and main issues concerning national
  policies, economic issues and regulation and
  registration of herbal product in selected
  countries,
• A proposal on common requirements will be
  adopted, and
• A proposed plan of action to follow up
  conclusions and recommendations of the meeting.

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Regional Experts Meeting (2000)Recommendations
to Countries

• To adopt the requirements for registration of HM
  
• To establish a national expert advisory committee
  with representatives of stakeholders to determine
  which botanical products are to be subject to
  registration and regulation and, if necessary,
  determine which are not medical agents
• To promote the inclusion of TRM in the curricula
  for health professionals, mainly medical schools
  and, in the meanwhile, to develop special
  training programs to disseminate TRM concepts and
  practices among present medical doctors
• To establish of an information program on HM to
  the general public.

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Regional Experts Meeting (2000)Recommendations
to Countries

• 5. To establish a specific post marketing
  surveillance on the use of HM as part of the
  general drug post marketing surveillance
  program
• 6. To develop standards of good botanical
  practices to guarantee that each lot of raw
  material or plant material used to make a herbal
  drug should be completely identified. The
  creation of a herbal of reference is to be the
  responsibility of the manufacturer or supplier of
  raw material.

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Regional Experts Meeting (2000)Recomendations to
PAHO

• To develop activities such as seminars, workshops
  and similar activities for training on specific
  subjects on herbal medicine such as the
  implementation of safety, efficacy and quality
  control
• The Secretariat of the PANDRH to propose to the
  Steering Committee of the Network the
  establishment of a WG on HM. This WG would be
  coordinated by the NRA Mexico and be integrated
  with the following Member States which
  participated at this meeting
• Brazil Edmundo Machado Neto Chile Gonzalo
  Navarrete Canada Peter Chan Costa Rica Sandra
  Martinez Guatemala Judith de Castro Peru
  Enrique León Mexico Juan Hernandez Jamaica
  Grace Allen-Young OECS Francis Burnett
• This group to be presented at the next Pan
  American Conference on Drug Regulatory
  Harmonization
• WHO should develop Guidelines on good
  agricultural practice of medicinal plants.

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Background (Americas) II

• Establishment of a WG on Medicinal Plants by the
  III Conference (2002)

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Background (Americas) III

• Regional Meeting on MTR to discuss (2003)
• Regulation
• Quality Control
• Safety and Pharmacovigilance

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Regional Meeting on MTR (2003)Participants

• ARGENTINA Claudia Beatriz Carino
• BOLIVIA Alberto Giménez Turba
• BRASIL Edmundo Machado NettoCésar Piniteiro
  Jacoby
• CANADA Robin MarlesDuc Vu
• COSTA RICA Kattia María Rosales
• CHILE Margarita Alicia Saéz
• EL SALVADOR Juan Manuel Chicas Vásquez
• ECUADOR Milton Jijón Arguello
• GERMANY Konstantin Keller
• HONDURAS Juan Almendares
• JAMAICA Princess Thomas Osbourne
• MEXICO Federico S. Meixueiro Ortiz
• NICARAGUA Nubia Argentina Blanco Sampson
• PANAMA Mahabir Prashad Gupta
• PERU Carlos Gustavo Del Aguila Campos
• REP. DOMINICANA Juan Agustín Alcantara Gómez
• U S A Harry H. S. Fong
• GUATEMALA Marta de Alvarez Beatríz de
  Jiménez
• WHO and PAHO

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Regional Meeting on MTR (2003)Objectives

• To analyze the status of the national policy in
  AMRO through country presentations and the
  preliminary results of the WHO Global survey on
  Traditional and Complementary/Alternative
  Medicine
• To introduce WHO-TRM strategy materials and
  facilitate discussion on topics recommended from
  previous meetings, especially those of safety
  monitoring and quality control
• To discuss and determine the kinds of technical
  advice and support needed by the Member States
  and AMRO on the emerging topics in Traditional
  and Complementary/Alternative Medicines to be
  provided by WHO-TRM and AMRO/PAHO.

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Regional Meeting on MTR (2003)Outcomes

• Recommendations on
• Regulation of HM
• (2) Quality control of HM
• (3) Safety monitoring of HM
• (4) Rational use of traditional medicines and
• (5) Challenges for regulatory harmonization in
  the field of quality control, safety monitoring
  and proper use of HM by consumers.

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Regional Meeting on MTR (2003)Recommendations

• REGULATORY ASPECTS
• Establish a mechanism of exchange of information
  among countries on regulation, quality, safety,
  and rational use of herbal medicines.
• Participating in/Establishing an international
  network for information exchange.
• Update WHO document Regulatory situation of
  herbal medicines a world wide review
• Facilitate exchange of information on herbal
  medicines among Member States through different
  measures and tools. There is a need for
  harmonization, from marketing point of view, as
  different regulatory classifications are given to
  a same product among countries in the Region.
• Harmonize definition and classification of
  selective herbal medicines and herbal products in
  the Region, through the work of the Pan American
  Working Group on Medicinal Plant.

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Regional Meeting on MTR (2003)Recommendations

• QUALITY ASSURANCE (I)
• The quality assurance measures should be applied
  at all the different stage of production of
  herbal medicines including good agricultural and
  field collection practices (GACP) for medicinal
  plants, good manufacturing practices (GMP) and
  post marketing surveillance.
• Review and update of the current national quality
  assurance system by incorporating measures such
  as GACP and GMP.
• Consider to develop national GACP guidelines
  (general guidelines and/or specific guidelines on
  selected medicinal plants).
• Finalize the draft WHO guidelines on GACP for
  medicinal plants.
• Provide Technical assistance to the Member
  States.

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Regional Meeting on MTR (2003)Recommendations

• QUALITY ASSURANCE (II)
• Need to establish quality standard and
  specification of herbal medicines, including
  identification of marker substances for quality
  control purpose.
• Preparation of national monographs on native
  medicinal plants.
• Exchange of information on existing national
  monographs on medicinal plants in the Region.
• Establish and strengthen research collaboration
  with research institutions and universities,
  required for quality control of herbal medicines.
• Finalize the draft updated supplement GMP for
  herbal medicines.
• Develop new technical guidelines relating quality
  assurance and control of herbal medicines,
  including possible marker substances for quality
  control purpose.

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Regional Meeting on MTR (2003)Recommendations

• QUALITY CONTROL
• Strengthen the national reference laboratories
  capacity for quality control of herbal medicines.
  
• Training of personnel of the national quality
  control laboratories.
• Provide technical guidance on analytical methods
  of herbal medicines required at the national
  quality control laboratories.

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Regional Meeting on MTR (2003)Recommendations

• SAFETY
• Define the strategy of approach in order to
  establish the national program on safety-,
  monitoring of herbal medicines.
• Strengthening participatory processes.
• Collaborate with existing national
  pharmacovigilance centres in the Region, for the
  exchange of information and possible technical
  cooperation.
• Participate in the development process of WHO
  Guidelines on safety monitoring and
  pharmacovigilance of herbal medicines.
• Organize national workshop at the community
  level, for exchange of information and to explore
  possible options/criteria in establishing a
  national system for safety monitoring of herbal
  medicines
• Finalize the draft WHO guideline on safety
  monitoring and pharmacovigilance of herbal
  medicines.
• Organize training workshops for national capacity
  building on safety monitoring of herbal medicines.

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Regional Meeting on MTR (2003)Recommendations

• RATIONAL USE
• Establish programs for provision of information,
  both to providers and consumers, on the proper
  use of herbal medicines and other Traditional
  Medicine (TM)/Complementary and Alternative
  Medicine (CAM) products and therapies, based on
  the WHO guidelines for consumers on proper use of
  TM/CAM.
• Develop information materials/tool for consumers
  on proper use of TM/CAM.
• Finalize the draft WHO guideline for consumers on
  proper use of TM/CAM.
• Organize training workshop for Member States on
  proper use of TM/CAM by consumers.
• Promote education and training on herbal
  medicines for health care services providers.
• Incorporate subjects relating to herbal
  medicines, in the curricula of the Health care
  professionals and Health workers, in order them
  to acquire adequate technical knowledge and
  skills on herbal medicines and to promote its
  proper use.
• Provide technical guidance on basic education and
  training for providers of herbal medicines and
  for others of selected TM/CAM.

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Background (Americas) IV

• I meeting of the PANDRH WG on Medicinal Plants

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I meeting of the PANDRH WG on Medicinal Plants
(Feb 2003)

• Mission
• Objectives

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Background (Global)

• International Regulatory Cooperation for Herbal
  medicines (IRCH)
• Established in Dec 2005
• 1rst meeting. Dec 2005. Canada
• 2nd Meeting. Oct 2006. China
• Mission IRCH is a network to protect and promote
  public health and safety through improved
  regulation for HM.
• PANDRH invited to be part of IRCH.
• A member will be selected regulator, member of
  the WG, English. Proposal must be approved by the
  SC.

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Background (Global)WHO DOCUMENTS

• WHO/TRM Legal Status
• WHO/TRM Consumers Guideline
• WHO/TRM Research Evaluation
• WHO/TRM Regulatory Situation of Herbal Medicines
• Good Agricultural Practices

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Muchas gracias Thank You