Development of Integrated Information Management System for EAC Partner States National Medicines Regulatory Authorities Currently Underway

22 Jul 2021

East African Community Headquarters, Arusha, Tanzania, 21st July, 2021: A technical meeting of the EAC Medicines Regulatory Harmonization (EAC-MRH) Programme to develop an Integrated Information Management System (IIMS) for National Medicines Regulatory Authorities (NMRAs) is underway in Karatu, Tanzania.

The EAC has been implementing the MRH programme since March 2012 with the aim of harmonising technical requirements and optimising processes for medicines regulation to facilitate timely access to safe, affordable, efficacious and quality essential medicines, vaccines and medical devices for treatment, management and diagnosis of diseases of public health importance.

The purpose of the IIMS will be to store data and manage drug regulatory information necessary for timely decision making by National Medicines Regulatory Authorities. In addition, the system will provide pharmaceutical industry stakeholders access to updated harmonised guidelines and tools to ensure manufacturing is carried out according to EAC good manufacturing practices standards.

Once complete, the common information management system, which will be linked to all Partner States and the EAC Secretariat and will facilitate implementation of harmonised regulations, guidelines, templates and tools for medical products, vaccines and medical devices in line with Article 118 of the Treaty of the Establishment of the EAC.

One of the key objectives of the EAC MRH Programme is to streamline the regulatory processes across the region for introduction of new medicines and vaccines for treatment of emerging diseases such as COVID-19 and clinical trials. In line with this objective, the IIMS will host information on joint scientific review of medical product dossiers, reports on joint inspections of pharmaceutical manufacturing facilities to assess compliance with good manufacturing practices (GMP) as well as information on joint safety and quality market surveillance of medical products in the regional market.

The EAC is one of the first Regional Economic Community (REC) in the continent that identified the importance of medicine regulatory harmonization. It is part of the African medicine Regulatory Harmonization (AMRH) initiative whose aim is to address the concerns of lack of standardised approaches in medicine regulation.

Such lack of standardisation results in cumbersome and non-transparent processes for medicine registration creating uncertainty and high costs for the manufacturers registering medicines. The EAC Secretariat hopes that with the interlinked and interoperable IIMS, the aforementioned challenges will be a thing of the past.

Easy and quick availability of information will go a long way in ensuring that the EAC-MRH programme is better placed to bridge the policy-to-implementation gap that has been hampering advances in access to essential medicines and vaccines.