USP Moves Drug Quality Pilot Program into Sub-Saharan Africa - Pharmaceutical Technology

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USP Moves Drug Quality Pilot Program into Sub-Saharan Africa


ePT--the Electronic Newsletter of Pharmaceutical Technology

The United States Pharmacopeial Convention (USP) launched a 12-month pilot Technical Assistance Program (TAP) to provide developing countries in sub-Saharan Africa with greater capacity to test the quality of medicines, according to a Feb. 8, 2011, USP press announcement. Under TAP, participating countries (Ethiopia, Ghana, Kenya, Senegal, and Sierra Leone) will receive a comprehensive package of pharmaceutical reference standards, documentary standards, and technical training. The goal is to improve these countries' efforts to ensure drug quality for their citizens.

Each of the participating countries has committed to improving public health, says the USP release. Several of the sub-Saharan African nations participating in TAP have also been part of USP’s Promoting the Quality of Medicines (PQM) program, which is funded by the US Agency for International Development and focuses on removing substandard and counterfeit medicines from the market. TAP will complement and reinforce PQM’s work.

“I am very pleased that USP is able to launch this important pilot program in support of vulnerable populations,” said Roger L. Williams, MD, USP’s chief executive officer, in the press announcement. “The ability to test essential medicines using good quality standards is a crucial component of efforts to improve public health. The countries in this pilot are committed to strengthening drug quality and lack of key resources should not stand in their way. As a physician, I’m particularly interested in the broadest possible access to high quality, affordable medicines.”

The fact that the USP standards will be provided at no cost to the participating TAP countries is unique. Traditionally, reference and documentary standards are sold to pharmaceutical manufacturers and quality-control laboratories, leaving organizations with few resources unable to purchase the most current standards.

Patrick Lukulay, PhD, director of the PQM program, points out that, “Without good reference standards, test results produced by laboratories are questionable at best. USP’s Technical Assistance Program will increase the extent and scope of quality control and regulators will be able to exercise better oversight of medicines quality in their markets,” he said in the release.

At the end of the pilot program, USP and the five participating countries’ quality-control laboratories will assess progress in areas such as number and variety of drug samples tested, number of substandard or counterfeit drugs detected, and improved access to quality medicines. According to the pharmacopeia’s press announcement, “USP is emphasizing the need to measure, evaluate, and document activities and outcomes resulting from TAP projects. If the pilot is successful, support may be renewed or expanded with the initial participants, and the program also may be extended to other countries and include additional features.”

See related PharmTech articles
Recent Regulatory Efforts in Africa Aim to Fight Counterfeit Drugs (blog post)

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