Tag Archives | pharmaceutical regulations

Strengthening Medicine Registration in Benin: A Detailed Assessment

In November 2016, at the request of USAID/Benin, SIAPS conducted a rapid assessment of the medicines registration system of the Direction de la Pharmacie, du Médicament et des Explorations Diagnostiques (DPMED) in Benin and made recommendations to address the challenges arising from its current information system. The assessment identified opportunities to improve regulatory processes for the efficient and transparent registration of medicines. The purpose of SIAPS’s technical assistance visit in August 2017 was to conduct a situational analysis regarding the findings and recommendations made after SIAPS conducted a rapid assessment in November 2016. The goal was also to develop appropriate recommendations and a plan for the implementation of Pharmadex software and the management system of the medicines registration process at DPMED, Benin.

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Regulatory Systems Assessment Tool

As the availability of pharmaceutical products in low- and middle-income countries (LMICs) has improved in recent years, the need for functional national regulatory systems is becoming paramount in ensuring the safety, quality, and efficacy of those products. However, national regulatory authorities in LMICs struggle to fulfill their respective mandates to meet this increasing demand for their services in line with international standards. Outdated legal frameworks, inadequate staffing, inefficient processes, weak information systems, and insufficient financing are among the challenges they face. Increasingly, donors and development agencies are acknowledging the importance of regulatory systems strengthening and are looking for ways to work with national regulatory authorities to define and prioritize their system needs, identify feasible evidence-based and cost-effective system strengthening interventions, and support regulatory authorities to monitor progress toward their goals. RSAT examines the system components and regulatory functions of a national medicines regulatory system. It can be implemented by either National Medicines Regulatory Agency (NMRA) staff for the purpose of self-assessment and monitoring or independent assessors and technical assistance providers that provide support to NMRAs to pinpoint and prioritize the specific areas of the regulatory system that most need improvement to achieve greater efficiency and effectiveness. The tool is designed to populate a combination of quantitative and qualitative data from multiple pre-existing sources.

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SIAPS Showcases Key Approaches at Africa’s Medicine Regulation Conference, Accra, Ghana

The 3rd Biennial Scientific Conference on Medical Products Regulation in Africa (SCOMRA), which took place November 27–28, 2017, in Accra, Ghana, focused on “Sustaining the Momentum for Regulatory Harmonization in Africa.” Participants and presenters shared their experiences and lessons learned to contribute to the future of medical products regulation and harmonization in Africa. Staff from the USAID-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) program presented posters highlighting the program’s work and key findings. SIAPS’s participation in the conference was critical for highlighting the support the program has offered countries to strengthen their medicine regulatory systems since 2011.

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Rapid Evaluation of the Medicines Registration System in Benin

The director of the Department of Pharmacy, Medicines, and Diagnostics (DPMED) wishes to adopt suitable software to strengthen the registration system for medicines and other health products. Although computerization yields improvements in the management of regulatory information, its effectiveness will largely depend on the presence of adequate medicines registration procedures and the system’s overall compliance with regional and international standards. This rapid evaluation thus seeks to analyze and understand Benin’s regulatory information management system for medicines registration, make appropriate recommendations, and propose an action plan based on emerging outcomes.

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Registration and Quality Assurance of ARVs and other Essential Medicines in Namibia

SIAPS provided technical assistance to facilitate the expedited assessment and registration of new and existing ARV formulations to support the implementation of the revised Namibian ART guidelines (dated January 2014). The technical assistance focused on improving the efficiency of the regulatory system so that the recommended new first-line fixed-dose combination ARVs that contain tenofovir and emtricitabine for adults; optimized ARV formulations for pediatric use; and other medicines for HIV and AIDS; TB; maternal, newborn, and child health (MNCH); and other public health diseases are assessed and considered for registration and made available for public procurement in a timely manner to benefit patients undergoing ART.

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Strengthening Capacity for Monitoring and Evaluating Mozambique’s Regulatory System

In Mozambique, SIAPS has been working with the Ministry of Health’s (MOH) pharmaceutical department (PD), which functions as the country’s regulatory authority, to strengthen its capacity at the national level. The PD’s main function is to ensure access to safe, effective, and quality pharmaceuticals through the public and private sectors that contribute to the best possible health outcomes. One of the PD’s priorities has been to develop a monitoring and evaluation (M&E) system to assess department performance; improve transparency and ensure accountability; help guide the planning, coordination, and implementation of regulatory activities; and foster a culture of evidence-based decision making.

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Situation Analysis: Regulatory Data Management System of Philippines FDA

The goals of this situation analysis were to evaluate the current status of the PFDA’s overall regulatory information management system, with a focus on medicine registration data management, and to develop recommendations and an action plan to cultivate a more robust regulatory information management system, including the required IT solutions to manage licensing of drug establishments and the registration of pharmaceutical products, as well as other operations of the PFDA.

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Technical Highlight: Strengthening Regulatory Systems in Democratic Republic of the Congo to Improve Access to Safe, Effective, and Quality Medicines

Chronic underfunding of the health sector coupled with long-term civil unrest in the Democratic Republic of the Congo (DRC) has contributed to insufficient regulatory capacity to effectively manage the registration and approval of new medicines in the country. In partnership with the USAID-funded SIAPS Program, the country’s Ministry of Health supported a number of broad interventions to strengthen DRC’s pharmaceutical regulatory system. SIAPS provides technical assistance to the three national control programs—malaria, HIV/AIDS, and tuberculosis—to improving access to quality medicines and other commodities and increase the potential for achieving desired health outcomes.

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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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Strengthening Regulatory Systems to Improve Access to Safe, Effective, and Quality Medicines

SIAPS technical support has helped strengthen the capacity of the national registration committee and streamline medicines registration. As a result, the number of registered medicines has increased from 200 in 2010 to over 3,000 in 2014; 72% of the medicines included on DRC’s essential medicines list currently have at least one product registered, up from 44% in 2011. The backlog of applications has been completely eliminated and the time taken to process a new application has been reduced from a peak of 85 days in 2013 to 64 days at the end of 2014.

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