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

Helping to increase the availability of affordable, high-quality medicines to treat patients worldwide suffering from multi-drug resistant tuberculosis, technical assistance provided at no cost to manufacturers under the Promoting the Quality of Medicines (PQM) programa U.S. Agency for International Development (USAID)-funded program that is implemented by the U.S. Pharmacopeial Convention (USP)has yielded its first anti-tuberculosis medicine to achieve prequalification status from the World Health Organization (WHO). Produced by Korea-based Dong-A Pharmaceutical Co. Ltd, the medicine is Cycloserine, 250 mg capsule. ZinCfant 20 mg dispersible tablet, produced by France-based Nutriset/Laboratoire Pharmaceutique Rodael for managing diarrhea in children, additionally achieved WHO prequalification status with assistance from PQMsupporting PQM's work with other health programs relevant to USAID, including maternal and child health programs.

According to WHO, its Prequalification of Medicines Programme, "evaluates and assures the quality of medicines bought by international aid programmes and countries with weak pharmaceutical regulation." This improves treatment results in developing countries and beyond. The program was originally developed to aid United Nations (UN) agencies that were procuring large quantities of HIV/AIDS medicines for developing countries in their purchasing decisions. Under the program, WHO comprehensively evaluates the quality, safety and efficacy of medicinal products based on information submitted by manufacturers and inspection of the corresponding manufacturing and clinical sites. Its list of prequalified medicinal products is a vital tool that today is widely used beyond UN agencies by a range of groups involved in purchasing medicines in bulk. It now covers medicines to treat malaria, tuberculosis and those used for reproductive health. Given the mandate of many organizations that only medicines prequalified by WHO or approved
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Contact: Francine Pierson
fp@usp.org
301-816-8588
US Pharmacopeia
Source:Eurekalert

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