The Ethiopian Food and Drug Authority (EFDA) oversees the licensing, market authorization, and import permit approval for medical and food products for a variety of vendors from many countries. The USAID Digital Health Activity (DHA) designed and introduced an Electronic Regulatory Information System (eRIS) to facilitate the country’s licensing, inspection, registration, and import permit process.

I-License, a critical part of eRIS, is an open-source, web-based application used to digitize the process of securing certificates of competency (COCs). i-License allows importers, exporters, wholesalers, and manufacturers to apply for COCs required to register or import products into Ethiopia. For the EFDA, i-License provides an online portal for accepting, reviewing, and authorizing these applications. Throughout the licensing process, it is also used to manage decision-making, associated documents, and communication between EFDA and applicants. Once a facility is registered via i-License, it enters the market authorization and import permitting process, which is managed via other components of the eRIS, namely the i-Register and i-Import applications, respectively.

Pharmaceutical expert Samuel Meri is a team leader for the Medical and Cosmetic Licensing and Inspection Directorate of the EFDA. Before i-License, Samuel worked with the licensing and inspection team, which allowed him to closely observe the work prior to and following the implementation of i-License in the directorate. According to Samuel, i-License has made a number of positive changes to the EFDA’s licensing and inspection division. One significant advantage mentioned of i-License is that it gives the directorate a great deal of transparency. This means that the work being processed by the team is accessible to staff members, and a team leader or director can easily track an application, spot any flaws, and offer a solution as soon as one is required. “After i-License was introduced to the directorate, it was simple to access, track, and manage any documents. Prior to i-License, we had to manually gather all documents, making it difficult to quickly find,” said Samuel.

Samuel also said that by requiring less time and effort from the directorate team and applicants to submit a COC application, i-License has reduced the workload for staff members. In addition, applicants are more appreciative of the work of the directorate team.

However, false documents being uploaded and submitted by applicants is a serious challenge faced by staff currently. According to Samuel, prior to the implementation of iLicense, when applicants were required to present their documentation in person, the team was able to examine and return the documentation immediately if there were problems. Now that there has been so much back and forth for document verification, Samuel said, there has been some additional lag time, but regulation is not evaluated by quality, not quantity, which helps.

Lastly, i-License has reduced physical traffic at the office for routine tasks. For example, applicants no longer need to visit the office to submit their COC applications, registration, or import permits. Applicants can use the online system to track any applications they have submitted to the authority. Now the majority of candidates only come to the directorate to gather information or pick up their certificates.

Overall, i-License has greatly improved the quality and ease of COC processing for the EFDA. It is just one of the many advantages offered by the eRIS that will continue to strengthen Ethiopia’s health system – and contribute to its information revolution – for this generation and those to come.

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