A1260212420MVcon

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Supply and quality of antimalarial medicines and
diagnostics introduction of issues Dr Andrea
Bosman Global Malaria Programme
RBM Case Management Working Group (CMWG)
Geneva, 9 July 2009
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Quality requirements of artemisinin-based
antimalarial medicines

• The built-in chemical instability of
  artemisinin and
  its derivatives, necessary
  for their biological action,
  causes pharmaceutical
  problems both in the
  manufacturing process and in
  the co-formulation
  with other compounds. The
  problems of instability
  are accelerated under
  tropical conditions.
• The requirement for observing stringent
  quality
  manufacturing standards are particularly
  important for these compounds, for which
  manufacturers and national regulatory authorities
  have limited experience.
• Differences in product quality selection
  criteria create opportunities for sub-standard
  artemisinin-based antimalarial medicines to
  access international funds for procurement, and
  discourage compliance with more stringent quality
  standards.

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Inter-agency harmonized criteria for the
selection of artemisinin-based antimalarials
GFATM QAP criteria
UNICEF/WHO tender criteria

• WHO Treatment Guidelines
• PQ approved or SRA-registered
• Dossier accepted by PQ or SRA
• GMP compliance after inspection
• by WHO PQ or SRA

• Inclusion only
• in National
• Treatment
• Guidelines

• Restricted
• annual joint
• tender

• Dossier
• submission
• only to
• SRA

Review of efficacy and safety

• Evaluation of IPPQ
• - registration information,
• - regulatory (licensing) situation,
• - finished product specifications and
  compliance
• with International Pharmacopoeia standards,
• - stability data (in Zone IV),
• - labeling information,
• - API characteristics and certification.