Policy and regulation group

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Policy and regulation group

• Co-chairs Bola Omoniyi
• Mohammed Farah
• Rapporteur Merlin Willcox

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Top issues

• Recognition of traditional practitioners AND
  traditional medicine (refined and crude) by
  communities, Ministries of Health and WHO
• Relevant policies in national health and national
  drug policies
• Dissemination of practical information on how to
  use antimalarial plant products
• Training in herbal medicine

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More issues

• Collection of information for registration
  dossier
• Safety recommendations
• Clinical trials
• Guidelines for regulators
• Expand market potential
• Follow-up on actions pledged!

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Recognition

• Certification of Traditional Healers
• Grassroots level traditional healers associations
• Legal framework to protect practitioners, with
  provision for intellectual property rights

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Policies

• Malaria control policies recognising potential
  role of traditional medicines and traditional
  practitioners

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Dissemination of information

• National strategies on communication of
  information on traditional medicines
• Sharing of information between traditional
  healers
• Practical booklets of information for communities
  on how to cultivate, prepare and use plants for
  treatment and prevention of malaria.

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Training

• Multidisciplinary approach (botany,
  phytochemistry, pharmacy, diagnosis, safety)
• Train existing practitioners in-service
• New trainees
• Conventional health practitioners

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Collecting information for registration dossier

• Practitioners should document in their local
  language
• Mini-monographs on top 50 antimalarial herbs

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Safety recommendations

• GACP, GMP, analytic control (GLP)
• Investigate genotoxicity
• Need to define what standards to apply
• Determine risk-benefit (severe vs uncomplicated
  malaria)
• Pharmacovigilance system

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Clinical trials

• Complete dossier / bibliographic dossier both
  options
• Encourage funders to fund clinical trials

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Guidelines for regulators

• Adopt and implement WHO guidelines for
  registration
• Harmonisation of guidelines between countries
• Move towards mutual recognition and centralisation

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Expand market potential

• List for each African country of common herbal
  antimalarials sold
• Waive / reduce registration fees for herbal
  antimalarials
• Advocate for orphan drug status
• Standardise, register, clinical trials

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Follow-up

• Document the actions that are taken
• Follow-up with members of each group

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What we will do

• Joseph Yano (Kenya) develop registration process
  for herbal drugs in Kenya
• Hashim Yusuf (Nigeria)
• Advocate within the Nigeria regulatory authority
  and MoH to have a special focus on antimalarial
  products, to facilitate registration.
• Advocate to carry recommendations to WHA.
• Advocate in West Africa for harmonisation of
  regulatory policies
• Bruno Dery document good practice on Ghanaian
  regulatory policies for herbal medicines.

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What we will do (2)

• Grace Nakamwagi
• Take recommendations to regulatory authorities in
  Uganda
• Arrange collaboration between Malaria consortium
  and herbalists
• Clive Ondari (WHO) follow up with WHO about
  updating Traditional Medicine strategy

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What we will do (3)

• Prof Vlietinck
• Help for training
• Advocating in London to take up malaria for
  orphan drug status
• Mesia Gauthier
• Local inventories of herbal antimalarials in
  Congo

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What we will do (4)

• Thomas Brendler (AAMPS) develop monographs
• Mohammed Farah (AMPS) Work on guidance on safety
  issues for herbal antimalarials in monographs

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What we will do (5)

• Merlin Willcox (RITAM)
• Collaborate with AAMPs on mini-monographs of
  antimalarial plants
• Encouraging clinical trials
• Information dissemination (devlpractical
  information)
• Ask other members of RITAM to help
• Bola Omoniyi Follow-up with members of the group
  to document what they did

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What we will do

• Work together for herbal antimalarials!