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Research: The role of pre-shipment batch testing in ensuring good medicine quality

December 5, 2012 - 16:50 -- Bart G.J. Knols
Roger Bate, Kimberly Hess
MWJ 2012, 3, 12
Article type: 

Most donor agencies only procure drugs approved by a Stringent Regulatory Authority or the World Health Organization (WHO) Prequalification Programme in an effort to ensure high quality. This study compares the quality of artemisinin-based combination therapies (ACTs) produced by WHO-approved manufacturers with non-approved manufacturers and suggests policy changes to improve quality of donor-procured drugs. The results of this study suggest that ACTs produced by WHO-approved manufacturers perform nearly five times better than those of non-approved manufacturers, but some approved ACTs have too little active pharmaceutical ingredient. The US President’s Malaria Initiative tests every batch of every drug it procures before distribution to recipient countries. Other donors should follow suit to ensure that drugs purchased with taxpayer dollars are of the highest quality.

[The official response to this article from the World Health Organization Prequalification of Medicines Programme was published in December 2012 and is attached below]

PDF icon MWJ 2012_3_12.pdf141 KB
PDF icon AMFm_medicines_testing.pdf153.49 KB