The Ethiopian Food and Drug Administration (EFDA) is mandated, in the proclamation 661/2009, to ensure the safety, quality and efficacy of medicines. To achieve this, the authority has been working on different regulatory activities. The medicine market authorization system is one of the top priority areas that have been implemented. In addition to the dedicated assessors, the authority uses a national drug advisory committee for the assessment and registration of medicines. This has evolved through the years to improve the medicine dossier evaluation system. As the Socioeconomic development of the nation is transforming, there is a high flow of investments in the healthcare. However, the market authorization system available at this time is yet unable to satisfy and fully accommodate the demands coming into the country.
To address these issues, automation emplacement is demanding for the government. Hence, EFDA has developed medicine registration information system that is the conversant and demanding system to implement. This system ensures good governance, transparency, accountability, traceability and speed of work. In addition to this, medicine registration information system increases access to registered medicines information to different types of users in this endeavor. i-Import helps not only for dossier evaluation but also it has an online interface to help applicants to apply their application without the limitation to location. It is a web-based system.
Medicine Registration and Licensing Directorate strive to offer quality, safe and effective medicines in the pursuit of protecting public health through its competent and dedicated staffs. Currently the directorate consists of pharmacists, pharmacologists, public health specialists, clinical pharmacists, pharmaceutics experts, biomedical engineers and secretary.