- Todos > Quality and Safety: Medicines > Regulatory Support
- Todos > Health Technology Management > Inventory and Management Systems
- Palabras clave > data management
- Palabras clave > medicines registration
- Palabras clave > medicines registration systems
- Palabras clave > medicines regulation
- Palabras clave > medicines regulatory systems
- Palabras clave > national regulatory authority (NRA)
- Palabras clave > pharmadex
- Palabras clave > pharmadex - computerized assisted drug registration
- Palabras clave > web-based logistic data management
(2016; 32 pages)
Kim, EM. 2016. Strengthening the Medicine Regulatory System by Implementing an Electronic Medicine Registration Data Management System (Pharmadex) in Mozambique. 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.
The Pharmaceutical Department (PD) of the Ministry of Health (MOH) in Mozambique first introduced regulations for medicine product marketing authorizations in 1999. Since then, the PD has successfully registered approximately 4,200 pharmaceutical products, following a transition period during which it issued temporary product licenses. However, the PD has increasingly faced challenges with regard to efficient medicine registration processes. There is a significant backlog of applications due to the shortage of technical staff and the limitations of their technical capacity to conduct comprehensive reviews of medicine registration dossiers as well as of quality sample tests.
To implement the changes in the application review processes, in September 2015, the SIAPS team conducted:
- a mapping of the current medicine registration process;
- a review of the current regulatory framework, including laws, regulations, medicine registration guidelines, SOPs, and checklists; and
- then agreed to streamline the registration processes by implementing Pharmadex.
To introduce the system, the SIAPS team and the PD agreed to:
- digitalize archives of old and current medicine registration certificates and dossiers;
- convert the paper-based data to digital information; and
- improve the data management process through a new SOP.