Policy and regulation group

1. Policy and regulation group Co-chairs: Bola Omoniyi Mohammed Farah Rapporteur: Merlin Willcox

2. 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

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

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

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

6. 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.

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

8. Collecting information for registration dossier • Practitioners should document in their local language • Mini-monographs on top 50 antimalarial herbs

9. 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

10. Clinical trials • Complete dossier / bibliographic dossier – both options • Encourage funders to fund clinical trials

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

12. 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

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

14. 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.

15. 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

16. 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

17. What we will do (4) • Thomas Brendler (AAMPS): develop monographs • Mohammed Farah (AMPS): Work on guidance on safety issues for herbal antimalarials in monographs

18. 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

19. What we will do Work together for herbal antimalarials!