Medicines and Food Safety Unit
The Medicines and Food Safety Unit aims to “ensure a high level of consumer protection and restore and maintain confidence in the quality and safety of medicines, food and health products”.
The unit’s main objective is “to develop and facilitate implementation of regional policies, regulations strategies, guidelines and standards to enhance affordability, quality, efficacy and safety of human and veterinary medicines as well as ensure food safety in the EAC Partner States”.
The Medicines and Food Safety Unit is currently implementing the EAC Medicines Registration Harmonization (MRH) Project. This project is part of the African Medicines Registration Harmonisation (AMRH) Programme created to assist African countries and regions to respond to the challenges posed by medicines registration.
AMRH seeks to support African Regional Economic Communities and countries in harmonising medicines and aims “to improve public health by increasing rapid access to good quality, safe and effective medicines by reducing the time taken to register essential medicines for the treatment of priority diseases”.
The rationale for medicines harmonisation is based on the fact that most African countries implement disparate medicines regulatory regimes which lead to a lot of duplication of efforts and wastage of scarce resources and in turn, hamper the delivery of quality healthcare.
Drug regulatory harmonisation is, therefore, a desirable goal as it will effectively lead to:
- Quicker access to affordable, priority essential medicines of assured quality for patients;
- Improved public health outcomes;
- More effective medicines control by the strengthened national drug regulatory authorities;
- Improved procurement practices for securing priority medicines; and
- Cost efficiency for governments.
The EAC Medicines Registration Harmonisation (MRH) Project
The EAC MRH Project is supported by the World Bank and is part of the global effort to harmonise medicines regulations. It is envisioned that the following benefits will accrue from the implementation of the EAC MRH Project:
- Harmonised registration dossier format and technical requirements;
- Increased technical capacity and efficient use of resources;
- Increased applications for registration from manufacturers;
- Cost savings;
- Greater access to good quality and affordable medicines; and
- Greater impact on efforts towards reaching the Millennium Development Goals (MDGs) with regards to the three health-related MDGs (4 = to reduce child mortality, 5 = to improve maternal health and 6 = to combat HIV/AIDS, Malaria, and other diseases).