Transcript Policy and regulation group

Policy and
regulation group
Co-chairs: Bola Omoniyi
Mohammed Farah
Rapporteur: Merlin Willcox
Top issues
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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
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
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Malaria control policies recognising
potential role of traditional medicines
and traditional practitioners
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
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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
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Bruno Dery: document good practice on
Ghanaian regulatory policies for herbal
medicines.
What we will do (2)
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Grace Nakamwagi:
– Take recommendations to regulatory
authorities in Uganda
– Arrange collaboration between Malaria
consortium and herbalists
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Clive Ondari (WHO): follow up with
WHO about updating Traditional
Medicine strategy
What we will do (3)
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Prof Vlietinck:
– Help for training
– Advocating in London to take up malaria
for ‘orphan drug’ status
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Mesia Gauthier:
– Local inventories of herbal antimalarials
in Congo
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)
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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
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Bola Omoniyi: Follow-up with members of
the group to document what they did
What we will do
Work together for herbal
antimalarials!