PQM Annual Report: Oct 1, 2013 - Sep 30, 2014

The program is implemented by the U.S. Pharmacopeial Convention (USP) and serves as a primary mechanism to help address the growing development challenge posed worldwide by substandard and counterfeit medicines (SCMs). The PQM program has been operational since 1992, initially as the USP Drug Quality and Information program, and was re-established in 2010 as a five-year, $35 million cooperative agreement with USAID. In September 2013, USAID extended the PQM cooperative agreement through September 2019 and increased the budget ceiling by $75 million, for a total program ceiling of $110 million. PQM's objectives are to build capacity and strengthen quality assurance (QA) systems, help increase the supply of quality-assured medicines, and combat counterfeit and substandard medicines. To achieve these objectives, PQM provides technical assistance to countries in various regions, including Africa, Asia, Europe, Latin America, and the Middle East. In FY14, PQM provided technical assistance to 35 countries, strengthening their national capacity in quality assurance and quality control systems. The program helped national quality control laboratories (NQCLs) operate with good laboratory practices and become ISO/IEC 17025:2005 accredited or World Health Organization (WHO) prequalified. In FY14, PQM assisted 13 NQCLs in Africa, Asia, and Latin America, with several labs achieving ISO/IEC 17025:2005 accreditations or WHO prequalifications pending. PQM also assists countries in improving and streamlining their medicine registration systems to strengthen regulatory authorities' quality assurance. In FY14, PQM drafted guidelines and reviewed backlogs of dossiers in Ethiopia, and installed new web-based registration software and trained users in Guatemala. In addition, PQM helps increase the supply of quality-assured medicines by working with manufacturers to produce quality-assured medicines by following good manufacturing practices (GMP). In FY14, PQM conducted three workshops in Indonesia, Morocco, and the Philippines to inform manufacturers of anti-tuberculosis (TB) medicines how to produce quality-assured medicines. By the end of FY14, PQM was working with 47 manufacturers in 13 countries, with 3 anti-TB medicines becoming WHO Prequalified with assistance from PQM. PQM also provides technical assistance to manufacturers of essential medicines for maternal and child health to improve their GMP compliance. Through its work on GMP, PQM has strengthened its relationships with WHO, GDF, and UNICEF and expanded its role in preparing manufacturers medicines for WHO Prequalification. The PQM program has made significant progress in FY14, with notable achievements including the establishment of post-marketing surveillance in 26 countries, the identification of counterfeit and substandard antimalarial, anti-tuberculosis, obstetric, and neonatal medicines in several countries, and the strengthening of medicine registration systems in several countries. The PQM program is funded by USAID, with a total obligated amount of $14,461,846 for FY14. The program is implemented in several regions, including Africa, Asia, Europe, Latin America, and the Middle East, with a focus on countries where substandard and counterfeit medicines pose a significant public health threat. Overall, the PQM program is a critical initiative aimed at ensuring the quality, safety, and efficacy of medicines essential to USAID priority diseases. The program's objectives and activities are designed to address the growing development challenge posed worldwide by substandard and counterfeit medicines, and its progress in FY14 demonstrates its commitment to improving public health globally.