1 / 19

Policy and regulation group

This document outlines the critical discussions and action points from the Policy and Regulation Group focused on traditional medicine and its role in malaria control. Key issues include recognizing traditional practitioners, establishing relevant health policies, disseminating information on antimalarial plants, and standardizing registration processes. The group emphasizes the need for training, collection of safety data, and harmonizing guidelines across nations. Collaborations and follow-ups with various stakeholders will enhance the efficacy of herbal antimalarials and support sustainable malaria control strategies.

tara-nelson
Télécharger la présentation

Policy and regulation group

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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!

More Related