High prevalence of livestock diseases is a major constraint to increasing farmers’ incomes and enhancing agricultural development, food security and resilience. Availability and accessibility of high-quality veterinary medicines are considered key to combating animal diseases and helping to curb economic losses, however, registering veterinary medicines in Africa through the currently established processes is cumbersome and time consuming. Additionally, there is no overarching framework or governance structure for cooperation between agencies responsible for veterinary medicines in Africa.

The project ‘Better Regulation’ will significantly improve the predictability, efficiency and transparency of regulatory processes required to bring new veterinary products into market by assisting countries in sub-Saharan Africa to establish competent and sustainable national regulatory agencies. The project seeks to support the development of a long-term governance structure to improve access to high quality veterinary medicines through better regulation in a coordinated manner.

Improving the registration system for veterinary medicines across nations and harmonising the requirements will simplify the process, save time and resources, and help to ensure the quality, safety, and efficacy of veterinary products. This will also increase products’ availability, contributing to improved animal health and livestock production. The project includes the following key workstreams:

• Evaluating the potential for a sub-Saharan Africa governance structure to improve access to high quality veterinary medicines through better regulation.
• Piloting and promoting uptake at regional and global level of a self-assessment tool for regulators to objectively assess and strengthen regulatory capacity for veterinary medicines.
• Improving the efficiency and sustainability of the EAC MRP.

The project is supported by the Bill & Melinda Gates Foundation, and implemented by GALVmed, the World Organisation for Animal Health (WOAH), the UK Veterinary Medicines Directorate (UK-VMD) and the East African Community (EAC).

‘Better Regulation’ builds on core prior efforts and investments to improve regulatory harmonization across sub-Saharan Africa: the East African Community Mutual Recognition Procedure (MRP).

Availability of quality, safe and efficacious veterinary medicines in countries for use by livestock keepers depends on a reliable system of registration. In sub Saharan Africa, the process of registration is often unpredictable, lengthy, resource-intensive and a key barrier to investment by the private sector.

Since 2010, GALVmed and its partners, AU-PANVAC and HealthforAnimals, has been supporting the East African Community (EAC) to implement a mutual recognition procedure (MRP) in the EAC Partner States (Burundi, Kenya, Rwanda, South Sudan, Tanzania, Uganda and more recently Democratic Republic of Congo) that allows for simultaneous application of marketing authorisations in multiple countries. This saves time and allows countries and applicants to use their resources more efficiently. MRP increases the likelihood for the sustainable supply of quality, safe and efficacious registered veterinary medicines in the region. MRP is available for registration of veterinary pharmaceuticals and vaccines and will soon be extended to include registration of veterinary pesticides.

The MRP system does not replace the national system of registration and can be used for:

1. New product applications: When an applicant wishes to obtain a marketing authorisation for a new product in more than one Partner State simultaneously.
2. Expansion of markets into MA other EAC Partner States: When an applicant already has a marketing authorisation in one Partner State and wishes to expand sales of the registered product into one or more additional Partner States.

MRP runs to a specific timetable and all participating national regulatory agencies in the EAC Partner States have agreed to prioritise MRP applications over those received through the national process.

1. Mutual Recognition Procedure for the registration of Veterinary Medicines in the East Africa. Download here.
2. Working together to uniformly license veterinary medicines in East Africa: How the East African Community’s Mutual Recognition Procedure works. Download here.
3. MRP technical guidelines including application forms and templates are available here.