Initiative to Support & Enhance Medicine Quality Assurance Launched in Latin American and the Caribbean

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Efforts to explore sustainable mechanisms for South-South collaboration to help assure the quality of medicines in the region.

Although countries improved significantly their quality assurance systems throughout the years, there are still gaps in the region that need to be addressed.

Representatives from 16 Latin American and Caribbean countries laid the foundation for a regional mechanism for South-South collaboration for quality assurance of medicines during a workshop held in Lima, Peru on November 11-13, 2014.

The event, coordinated by the Promoting the Quality of Medicines (PQM) program in the context of the Amazon Malaria Initiative (AMI), brought together officials from Medicines Regulatory Authorities (MRAs) and Official Medicines Control Laboratories (OMCLs), as well as representatives from selected regional Schools of Pharmacy, to explore possible sustainable mechanisms to implement South-South collaboration for the quality assurance of medicines, using technical and human resources available in the Americas region.

In organizing the workshop, the PQM program, which is one component of the USAID-funded Amazon Malaria Initiative, recognized that to address the quality assurance needs of the region, it was necessary to expand the circle of stakeholders beyond those directly involved in medicines regulation in the countries participating in AMI, while building on their experience in networking.

“PQM has been collaborating extensively with the Pan American Health Organization and USP, to support countries’ quality assurance and quality control systems in the region, in order to help ensure the quality of the medicines available to the population,” said Dr. Victor Pribluda, PQM Manager of Latin American and Caribbean Programs. “This support contributed to OMCLs having enhanced technical capabilities and achieving ISO 17205 accreditation or WHO prequalification, and MRAs improving registration practices or establishing and institutionalizing the 3-level approach for the quality control of malaria and other medicines in decentralized areas. Although countries improved significantly their quality assurance systems throughout the years, there are still gaps in the region that need to be addressed. PQM envisioned this workshop as a forum to explore sustainable mechanisms for South-South collaboration, to facilitate the access and use of regional resources by countries’ institutions, independently of the technical or financial assistance provided by international programs and organizations.”

The participation of academia in the workshop was enthusiastically received by attendees since it recognized the benefits that both governmental institutions and academia may gain from these interactions; not only in services that Schools of Pharmacy could provide, but also in the impact that MRAs and OMCLs requirements may have on curricula at the learning institutions. Selected country representatives committed to follow up on the workshop initiative by collaborating with PQM and PAHO in writing a Concept Note detailing the conclusions and proposals developed during the meeting and also in developing a rapid survey tool to assess regional capabilities and needs in terms of quality assurance of medicines. The Concept Note and the completed survey will be presented to the Ministries of Health for their evaluation of this novel regional framework for sustainable South-South collaboration.

A new meeting will be convened during 2015 to further advance on this project after feedback is received from countries’ sanitary authorities; this meeting will also aim to expand representation to include additional countries in the Americas.

For more information, contact mediarelations(at)usp(dot)org and jachang(at)usaid(dot)gov.

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The Promoting the Quality of Medicines (PQM) program is made possible by the generosity of the American people through the United States Agency for International Development (USAID).

USP – Global Expertise, Trusted Standards, Improved Health

The U.S. Pharmacopeial Convention (USP) is a global health organization that improves lives through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP’s standards are used worldwide. For more information about USP visit http://www.usp.org.

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Nils Hagen-Frederiksen
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