- Palabras clave > computerized management - information systems
- Palabras clave > medicines registration
- Palabras clave > medicines regulation
- Palabras clave > Model System for Computer-Assisted Drug Registration (SIAMED)
- Palabras clave > registration software
- Palabras clave > regulatory systems
- Palabras clave > web-based registration system
(2014; 24 pages)
Duarte, K. 2014. Systems Requirements for Computerized Medicine Registration, Mozambique Ministry of Health. Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program. Arlington, VA: Management Sciences for Health.
In 2012, the US Agency for International Development-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program conducted a comprehensive assessment of regulatory systems in Mozambique and addressed the challenges of the current information system being used by the Mozambique Ministry of Health Pharmacy Department (PD) for medicine registration and other regulatory functions. Recommendations for changes include introducing an online computerized information management system to handle the registration process that can significantly improve the efficiency of registration and reduce the backlog by tracking the process, enhancing communications, and improving document management.
To address this gap, SIAPS was asked to do a follow-on assessment to evaluate the PD’s information system and related technical assistance needs for product registration as well as other regulatory functions. SIAPS then collaborated with the department to analyze system requirements to define data elements and identify an appropriate tool that is compatible with local technology and capacity.