East Africa bloc mulls harmonized medicines regulation to improve public health

The East Africa Community (EAC) on Thursday said that it is planning to harmonize the technical requirements for medicines regulation in order to boost public health systems across the region.

The EAC, a regional intergovernmental organization, said that harmonization will be achieved through the development of an integrated information management system (IIMS) for the national medicines regulatory authorities (NMRAs).

“The common information management system, will be linked to all partner states and the EAC Secretariat and will facilitate implementation of harmonized 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,” the secretariat said in a statement issued in Nairobi.

The EAC member states consist of Kenya, Uganda, Tanzania, Rwanda, Burundi and South Sudan.

It has been developing the Medicines Regulatory Harmonization (MRH) programme since 2012 to promote access to safe, affordable medicines of diseases of major public health concern.

The EAC harmonization programme is part of the African Medicine Regulatory Harmonization (AMRH) initiative whose aim is to address the concerns of lack of standardized approaches in medicine regulation.

The EAC Secretariat stressed that lack of standardization results in cumbersome and non-transparent processes for medicine registration creating uncertainty and high costs for the manufacturers registering medicines.

According to the trading bloc, 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.

“The system will provide pharmaceutical industry stakeholders access to updated harmonized guidelines and tools to ensure manufacturing is carried out according to EAC good manufacturing practices standards,” the secretariat said, adding that 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.