The Directorate of Drugs and Medical Supplies (DDMS) plays a key role in providing technical guidance and setting strategic direction in policy formulation, service delivery, standards, laws and regulations, and objectives for the pharmaceutical sector in Sierra Leone. It is also involved in stakeholders’ collaboration and coalition building, resource mobilization and deployment of resources, monitoring, … Read more
SIAPS helped improve pharmaceutical product quality by building the capacity of the Namibia Medicines Regulatory Council (NMRC) to review medicine registration dossiers; inspect pharmaceutical manufacturing facilities and finished (imported) products at ports of entry and in the marketplace; to chemically test medicines compliance with established standards; and monitor overall compliance with applicable regulatory standards and … Read more
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
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
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 … Read more
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 … Read more
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 … Read more
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 … Read more
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 … Read more
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 … Read more
