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GALVmed: Political will is critical for regulatory harmonization in Africa

The Global Alliance for Livestock Veterinary Medicines (GALVmed) has suggested gradual progress is being made in establishing a mutual recognition procedure in East Africa.

Since 2011, the Edinburgh-based organization has been working with the Bill & Melinda Gates Foundation and HealthforAnimals to bring a sustainable supply of veterinary vaccines to East Africa. Last year, the first licenses for a veterinary vaccine submitted for registration under the East African community's new mutual recognition procedure were issued. There are currently two more products in the process of registration.

Lois Muraguri, GALVmed's director of operational support and external affairs, said the project has been "resource light and progress has taken a long time".

Speaking at the recent UK & International Veterinary Vaccinology Network conference in London, Dr Muraguri stated: "It is important to engage stakeholders early in the process. Progress is faster where champions are identified and engaged. Political will at the East African community and national level are critical."

She also pointed out inter- and intra-country bureaucracy has slowed the adoption of the mutual recognition process in East Africa, while perceptions regarding the ownership of the project can also be a limiting factor.

Dr Muraguri said: "Building trust between assessors, inspectors and national regulatory authorities takes time and money."

She also highlighted the progress made by East African nations – Burundi, Kenya, Rwanda, South Sudan, Tanzania and Uganda – in terms of regulatory harmonization. The table below provides an overview of the steps made by these countries to date.

All but one of these nations has adopted harmonized guidelines. Burundi is currently establishing a national regulatory body for its animal health sector, which will allow it to implement the harmonized regulations and the mutual recognition procedure.

All of the countries aside from South Sudan have engaged with industry stakeholders in meetings to highlight the harmonized regulations.


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