Policy and regulation group

Co-chairs: Bola Omoniyi

Mohammed Farah

Rapporteur: Merlin Willcox

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

More issues… Collection of information for

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

Recognition Certification of Traditional Healers Grassroots level traditional healers

associations Legal framework to protect

practitioners, with provision for intellectual property rights

Policies 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.

Training Multidisciplinary approach (botany,

phytochemistry, pharmacy, diagnosis, safety)

Train existing practitioners: in-service New trainees Conventional health practitioners

Collecting information for registration dossier

Practitioners should document in their local language

Mini-monographs on top 50 antimalarial herbs

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

Clinical trials Complete dossier / bibliographic

dossier – both options Encourage funders to fund clinical

trials

Guidelines for regulators Adopt and implement WHO guidelines

for registration Harmonisation of guidelines between

countries Move towards mutual recognition and

centralisation

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

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

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.

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

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

What we will do (4) Thomas Brendler (AAMPS): develop

monographs Mohammed Farah (AMPS): Work on

guidance on safety issues for herbal antimalarials in monographs

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

What we will do

Work together for herbal antimalarials!