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First anti-tuberculosis medicine under USAID-supported PQM program achieves WHO prequalification
Date:2/7/2013

by a stringent regulatory authority are suitable for procurement, the increase in demand for prequalified products has stretched WHO's resources.

To address this resource gap, the PQM programwhich works to combat substandard and counterfeit medicines in developing countries and increase the supply of quality-assured medicinesoffers technical assistance providing support to interested manufacturers in achieving prequalification. PQM can assist with preparing product dossiers for submission to the WHO program; guiding manufacturers toward compliance with WHO good manufacturing practices; and addressing WHO comments on manufacturer submissions. The assistance is focused on "second-line" anti-tuberculosis medicines, which are used for multi-drug resistant tuberculosis. This form of tuberculosis is more difficult and lengthy to treatoften requiring up to two years of treatment. Poor-quality medicines can contribute to drug resistance and undermine desired treatment outcomes.

"The concept behind the assistance we provide to manufacturers is simple: by expediting the process of prequalification with WHO, we can help expand the pool of viable manufacturers and, in turn, increase the supply of quality-assured medicines. Ultimately, these medicines can help prevent unnecessary patient deaths, particularly among vulnerable populations including many women and children," said Ms. Cheri Vincent, Infectious Diseases Division chief of USAID's Global Health Bureau.

The PQM technical assistance program supports the Global Drug Facility (GDF)a pooled procurement system for anti-tuberculosis medicines operated under WHOin its efforts to improve access to quality-assured medicines. PQM, in collaboration with GDF, USAID and WHO, identify promising manufacturers that receive PQM technical assistance.

PQM offers technical assistance for 12 types of medications treating multi-drug resistant tuberculosis. PQM is currently working with approximately 20 ma
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Contact: Francine Pierson
fp@usp.org
301-816-8588
US Pharmacopeia
Source:Eurekalert

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