In November 2016, SIAPS offered technical assistance to DPMED to optimize the current medicine registration system, potentially by using the web-based medicine registration tool Pharmadex. After the assessment at DPMED in August 2017, SIAPS found that the SIGIP-ARP system in place was a software recommended for the regional West African Economic and Monetary Union (WAEMU) member states and was preferred by DPMED. Hence, it was jointly resolved to strengthen the system already in place. A server room was setup and a rack server installed to hold the current and any other future systems for DPMED (e.g., inspection software). SIGIP-ARP was modified to improve its performance, which has enabled DPMED to do concurrent data entry of registration applications. DPMED is currently progressing on this task, and SIGIP-ARP can generate monitoring reports, which the director can use for management purposes. DPMED has yet to develop monitoring and evaluation indicators to track the data entry.
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.
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 Outdated legal frameworks, inadequate staffing, inefficient processes, weak information systems, and insufficient financing are among the challenges they face.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.
A comprehensive assessment of DPM’s medicine regulatory system was conducted September to October 2017 by SIAPS funded by USAID. The WHO Global Benchmarking Tool was used for data collection. The scope of the assessment was focused on the five regulatory functions: national regulatory systems, medicines registration and marketing authorization (MA), pharmacovigilance (PV), market surveillance and control, and clinical trial oversight (CTO).
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