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 … Read more
Archive M Thumm
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 … Read more
Assessment of DPM Medicine Regulatory System, Mali
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 … Read more
Assessment of the Good Manufacturing Practices Inspection Program of the Bangladesh Directorate General of Drug Administration
As a part of its ongoing support to build the capacity of the DGDA, the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) team conducted a rapid assessment of the capacity of the Good Manufacturing Practices (GMP) inspection program at the Directorate General of Drug Administration (DGDA). GMP is part of the quality assurance … Read more
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 … Read more
Subnational Procurement of Maternal Health Medicines: Results from an Assessment in Bangladesh
SIAPS has developed a methodology and a set of tools to assess the effect of local procurement on the availability of maternal health medicines. SIAPS validated these assessment tools in Bangladesh to allow a broader discussion about potential strategies to improve access to maternal health medicines and to understand how local procurement practices affect access … Read more