Description of Session
Automation of supply chain systems (LMIS) and health management information (HMIS) has received a lot of attention and support in developing countries particularly over the past decade. However, pharmaceutical regulatory systems have generally speaking received far less attention. The business case for automation of regulatory information systems in Ethiopia grew initially from work automating LMIS, and anticipated benefits to extending that to regulatory processes. The Ethiopian electronic Regulatory Information System (eRIS) platform was conceived as automating all the functions of the Ethiopian Food and Drug Administration (EFDA), but was implemented in a modular bottom up fashion with EFDA prioritizing immediate needs. Currently, two modules of a planned comprehensive eRIS are fully operational: i-Import which approves medicine importation, implemented in 2017, and i-Register for market authorization/registration, implemented in 2018. Both are locally developed, open source solutions and are fully interoperable with the LMIS. All MIS use the same master data, and import requests made in the LMIS- synch to i-Import, as do import approvals and denials back to Vitas. Both systems were deployed initially for medicines and then extended to all regulated items including medical devices and supplies. Actual importation has also been automated and linked to the import approval process. Inspection and quality assurance, among other functions, are planned to be automated in the coming years. The system benefits from linkages between the various modules. For example, import approval (items and quantities) is now linked to actual items imported. And, linkages between importation and authorization facilitate ensuing only authorized items are imported. Standardizing master data has been an important system benefit and facilitator of success. The system is interoperable with the logistics management information system (LMIS). The agile modular approach to system development and deployment reduced risk and ensured the system met user requirements.
