A1260212420MVcon - PowerPoint PPT Presentation
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Title: 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.
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