Tag Archives | pharmaceutical regulations

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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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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Analysis of the Regulatory Capacity to Assure the Quality of Antimalarial Medicines in Selected Countries of the Greater Mekong Subregion of Asia

SIAPS conducted a review of regulatory and quality assurance efforts in the GMS with the following objectives—

  • To inform PMI of past and current initiatives to improve the capacity of the region to combat counterfeit, substandard, and banned antimalarial medicines
  • To understand the current barriers to effective medicine quality control for malaria
  • To recommend specific areas of focus or interventions to further improve regional and country capacity to combat counterfeit, substandard, and banned or illegal antimalarial medicines
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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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Assessment of the Medicines Regulatory System in Angola: Report

The Ministry of Health (Ministério da Saúde; MINSA)’s National Directorate of Medicines and Equipment (Direccao Nacional de Medicamentos e Equipamentos; DNME) is responsible for regulating medicines and other pharmaceutical products in Angola in collaboration with the Inspectorate General of Health (Inspecção-Geral da Saúde; IGS). Preliminary reports indicated that the regulatory system was not fully functional or operating effectively and thus needed assistance.

As a first step toward providing technical support and identifying additional sources of assistance to strengthen the regulatory system, the USAID-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program, which has been providing support to the DNME since 2005 in pharmaceutical management, particularly supply chain management, conducted an assessment of the system and DNME’s capacity to implement it.

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