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 Outdated legal frameworks, inadequate staffing, inefficient processes, weak information systems, and insufficient financing are among the challenges they face.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).
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 system for medicines, which helps to ensure that medicinal products are consistently produced and controlled to meet the quality standards appropriate to their intended use, as required by national drug regulatory authorities. The GMP inspection is also a critical component of the medicines registration review process.
To assess the capacity of the GMP inspection program of the DGDA, the SIAPS team reviewed onsite inspection practices as well as relevant documents. To evaluate the legal framework and current tools used by the DGDA inspectorate, the SIAPS team reviewed the applicable laws, regulations, standard operating procedures (SOPs), guidance documents, checklists, and inspection reports of the DGDA. To assess the current GMP inspection practices of the DGDA inspectorate, the SIAPS team accompanied DGDA inspectors to observe inspection practices at two GMP-certified manufacturing sites.
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.
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 to quality maternal health medicines at the district level.
Specifically, the assessment (1) measured the availability of maternal health medicines at selected storage and health care facilities to determine the medicines’ source, (2) evaluated local procurement practices being used at the district levels for essential maternal health commodities, and (3) compared those practices with national and international standards and guidelines. The results further identified options for strengthening local procurement practices and overall procurement strategies.
- The Use of Pharmaceutical Information for Decision Making in Namibia's National ART Program: Assessment Report
SIAPS conducted this assessment to determine the extent to which pharmaceutical information generated from the Electronic Dispensing Tool (EDT) and […]
The Directorate of Drugs and Medical Supplies (DDMS) plays a key role in providing technical guidance and setting strategic direction […]
- Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program Inventory of Key Technical Resources
The main purpose of this inventory is to serve as a reference to help stakeholders working in the pharmaceutical sector […]