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Antimalarial Medicines: Current Status in Africa

Antimalarial Medicines: Current Status in Africa. Dr Clive Ondari Medicines Policy and Standard Department WHO/HQ. Access framework. Rational. Sustainable. Selection & Use. financing. ACCESS. Reliable. Affordable. health and. systems. supply. prices. Scope of the presentation.

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Antimalarial Medicines: Current Status in Africa

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  1. Antimalarial Medicines: Current Status in Africa Dr Clive Ondari Medicines Policy and Standard Department WHO/HQ

  2. Access framework Rational Sustainable Selection & Use financing ACCESS Reliable Affordable health and systems supply prices

  3. Scope of the presentation • Situation analysis on antimalarials in Africa • WHO recommendations on combination antimalarials (ACTs) • Characteristics of ACTs (from a regulatory angle) • Process of regulation of antimalarials • Conclusions

  4. Situation analysis: the challenges • Quality of antimalarial drugs has been declining. • The efficacy of (affordable) antimalarial drugs has been declining (drug resistance) and high cost of replacement options. • 60-90% of the population seek initial treatment from non- public sector, i.e. street vendors, kiosks. • Supply of drugs is often inefficient and unreliable.

  5. Failure rates (%) – Content (2003)

  6. Failure Rates (%) – Dissolution (2003)

  7. Malaria distribution and reported case of resistance or treatment failure

  8. Factors leading to development of resistance • Lack of guidelines/poor drug treatment policies • Irrational prescribing • Irrational drug use • Drug concentration “tail” – poor formulations • Liberalized, uncontrolled drug market leading to poor quality products circulating in international and domestic markets

  9. FDC MDT Selection: Artemisinin-based Combination Therapies (ACTs) • Artemether/lumefantrine • Artesunate + amodiaquine ACTs • Artesunate + SP • Artesunate + mefloquine • Amodiaquine + SP

  10. ACTs are not typical “generic” products • Usually generic drugs “well established” … • ACTs are relatively new, or very new drugs • Limited information available in public domain • Most ACTs do not have quality standards • For most ACTs reference standards not readily available • Reference standards available only for those that have pharmacopoeial monographs • Difficulties of proving “interchangeability” • Regulators have limited experience with this group of drugs ...

  11. WHO Pre-qualification of ACT Products • Processes of Pre-qualification of manufacturers (of artemisinin-based combination antimalarial drug products) • Preparatory Phase • Drafting of specifications and guidelines (products and product files) • Publication of Expression of Interest (EOI) - IHT and WWW • Documentation Review Phase • Receiving of EOI (letter+files) • Screening, assessing, and reviewing dossiers  Report • Plant Inspection (GMP compliance) Phase • Team of inspectors appointed by QSM/EDM • Inspections carried out jointly with respective DRA • Reporting Phase • Results in a “white” list of products and manufacturers

  12. Cost implications of moving to ACTs Average cost per adult treatment (US$) (2002)

  13. Regulation of Medicines at National Level: • Drug Registration • Manufacturing (enforcing GMP standards) • Drug Distribution (scheduling: POM, PM, OTC/General Sales) • Information and Promotion Control

  14. Registration: • Safety • Efficacy • Quality • Affordability (pricing)

  15. Who may apply for registration • Manufacturer • Representative of a manufacturer (in the country of origin) – power of attorney required • An agent of a manufacturer (within the country) – power of attorney required

  16. Data required for approval of application • Chemical data (both active substance and formulating ingredients) • Pharmaceutical Data of the Product • Complete formula of the product (including specifications) • Manufacturing Processes (including validation data) • Analytical and quality specifications of the finished product • Method of analysis and assay of active ingredient in the finished product • Product stability profile • Clinical data (safety and efficacy)

  17. Clinical Data • Innovator product s • full documentation of preclinical and clinical safety and efficacy according to ICH guidelines • all claims on the SmPC have to be substantiated • Multi-source products • Bio-equivalance demonistrated • Direct evidence in support of safety and efficacy SMPC = summary of product characteristics

  18. Conclusions • In order to improve and sustain access to good quality, effective antimalarials in malaria-endemic countries, it will be necessary to intensify work to: • Develop and/or expand capacity for effective pharmaceutical regulation and control • Strengthen the capacity and efficiency of drug supply systems • Evolve more effective and efficient drug-financing arrangements • Ensure that antimalarial medicines are used in a rational manner

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