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Technical Highlight: Strengthening the Medicines Regulatory System in Swaziland

Swaziland is one of three remaining countries in the Southern Africa Development Community Region that do not have adequate regulatory and legislative frameworks to control the use, importation, manufacturing, and exportation of medicines. This is in the face of increased incidence of counterfeit medicines in the region; up to 25% of marketed medicines are substandard, and this is up to 64% for antimalarial medicines, according to a study conducted in 2011. Use of counterfeit and substandard medicines increases the burden of disease because of therapeutic failure, exacerbation of disease, and resistance to medicines. Swaziland’s weakness in medicines regulation and limited regulatory enforcement is also exploited by those smuggling prohibited and counterfeit medicines into neighboring countries.

 

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Systems Requirements for Computerized Medicine Registration, Mozambique Ministry of Health

In 2012, the US Agency for International Development-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program conducted a comprehensive assessment of regulatory systems in Mozambique and addressed the challenges of the current information system being used by the Mozambique Ministry of Health Pharmacy Department (PD) for medicine registration and other regulatory functions. Recommendations for changes include introducing an online computerized information management system to handle the registration process that can significantly improve the efficiency of registration and reduce the backlog by tracking the process, enhancing communications, and improving document management.

To address this gap, SIAPS was asked to do a follow-on assessment to evaluate the PD’s information system and related technical assistance needs for product registration as well as other regulatory functions. SIAPS then collaborated with the department to analyze system requirements to define data elements and identify an appropriate tool that is compatible with local technology and capacity.

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Swaziland Pharmaceutical Strategic Plan (2012-2016): Baseline Survey

Swaziland’s Ministry of Health has published its Pharmaceutical Strategic Plan, 2012-2016, serving as a roadmap for the revised national pharmaceutical policy. This report is intended to facilitate the monitoring and evaluation of implementation of the Strategic Plan. The report is a reflection of characteristics of the pharmaceutical sector in 2012.

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Assessment of the Regulatory Systems and Capacity of the Directorate General for Drug Administration in Bangladesh

The DGDA invited the USAID-funded SIAPS program to provide support for a comprehensive assessment of the Bangladeshi pharmaceutical regulatory system. The SIAPS program used the Regulatory Systems Assessment Tool (RSAT) to conduct a structured assessment of the DGDA, reviewed more than 50 documents, and conducted interviews with key informants. The assessment also reviewed the DGDA’s Operational Plan for Strengthening of Drug Administration and Management as contained in the Ministry of Health and Family Welfare (MOHFW) Health, Population, and Nutrition Sector Development Program (HPNSDP) strategic plan for 2011-2016.

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TB Pharmaceutical Management in Bangladesh June 24–July 12, 2012: Rapid Assessment

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The USAID-funded SIAPS project in Bangladesh is working toward improving access to and availability of quality pharmaceuticals and effective pharmaceutical services. The main objectives this assessment will support are—Strengthening of supply chain management systems of the MOHFW and component procurement entities with a particular focus on improving the tuberculosis (TB) supply chain management systems and Increasing transparent and evidence-based decision making with a specific focus on improving TB-related data collection and analysis.

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SIAPS, Mozambique: Program Description

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The focus of SIAPS’ support to DF will be improving the effectiveness, efficiency, transparency, and overall functioning of the regulatory system—including product registration, pharmacovigilance (PV), and inspection—to ensure the safety, efficacy, and quality of pharmaceutical products in circulation in the country. SIAPS will focus on improving pharmaceutical services at public hospitals, including the management of commodities, rational use of medicines, and patient safety.

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Haiti Pharmaceutical Sector Technical Assistance Priorities

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Access to medicines remains a major issue for the Haitian population. National-level statistics show that less than half the population has acceptable access to medicines. In addition, for those who have access, there is no guarantee of the quality of medicines. As part of the strategy to reform the health system, the MSPP has decided to develop a new NMP. This policy is a commitment from the nation to provide quality pharmaceutical services to the Haitian population on the basis of equity and justice.

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