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.
Model Business Process Flows for Registration of Medicines: A Guide for Establishing a Standardized Generic Version of SIAPS Pharmadex Software
The introduction of Pharmadex has so far targeted individual country requirements. Currently, under the African Medicines Regulatory Harmonization initiatives, efforts are underway to adopt common and harmonized processes and communication platforms for medicine registration in regional economic communities, such as EAC, ECOWAS, and the Southern African Development Community. The purpose of this report is therefore to describe the currently known processes in selected countries and develop a model set of business processes for medicine registration based on internationally accepted standards. These model business processes can then serve as the basis for establishing a model version of Pharmadex’s registration module.
Strengthening the Supply Chain Governance Framework for Pharmaceuticals and Health Products in the Philippines
The Department of Health (DOH) is ultimately responsible and accountable for ensuring that Filipinos have access to quality health services. An effective supply chain is essential for DOH to ensure that lifesaving health products are available, accessible, and effectively used for clients. Recently, the DOH has shown its commitment by creating the Supply Chain Management Unit (SCMU) in March 2016. SIAPS conducted a thorough desk review of previous assessments and DOH’s various internal SCM policies. SIAPS also helped coordinate meetings with various DOH offices to identify and validate current experiences in SCM and to obtain recommendations to strengthen SCM governance of DOH.
SIAPS conducted a training on pharmacovigilance (PV) to increase the capacity of the National Tuberculosis Program, the Lung Center of the Philippines, Pharmaceutical Division, and Food and Drug Administration. Strengthening the capacity of staff in these organizations and other stakeholders in this area of PV reinforces current safe scale-up efforts and introduction of these lifesaving regimens. Furthermore, providing training for staff in data management, causality assessment, and signal detection enhances expansion of safety monitoring to other medicines used within the health system in the Philippines.
The 3rd Biennial Scientific Conference on Medical Products Regulation in Africa (SCOMRA), which took place November 27–28, 2017, in Accra, […]
The director of the Department of Pharmacy, Medicines, and Diagnostics (DPMED) wishes to adopt suitable software to strengthen the registration system […]
In the last five years, SIAPS has provided technical assistance to the Namibia Medicines Regulatory Council (NMRC) to strengthen its capacity […]