Pharmacovigilance guidance for countries participating in AMFm Phase 1 (archived)
This document provides countries participating in the first phase of the initiative Affordable Medicine Facility for malaria (AMFm) with minimal standard procedures for preparing project plans to submit for funding. It is the product of a consultation on pharmacovigilance among international experts and technical experts from several countries, which was convened by the WHO Global Malaria Programme and the Medicines for Malaria Venture (MMV) on 6–8 April 2009 in Geneva, Switzerland.
The report describes why countries should prepare a pharmacovigilance strategy that takes into consideration the existing health infrastructure and post-marketing experience with artemisinin-based combination therapies (ACT). Pharmacovigilance systems are needed to monitor and ensure the maximum possible safety of ACT used in the AMFm programme.