Livestock Vaccinating a cow against East Coast Fever. Regulatory harmonisation will accelerate delivery of livestock health products to farmers. GALVmed/Karel Prinsloo
Regulatory harmonisation: Improving access to safe, effective and quality veterinary medicines across East Africa The costs of animal disease
from applicants. Harmonisation of
countries – Burundi, Djibouti,
In Africa, millions of people depend
the registration system for
Ethiopia, Kenya, Rwanda, Sudan,
on livestock for their livelihoods.
veterinary medicines across nations
Tanzania and Uganda. Only three
However, the high prevalence of
simpliďŹ es the process, saves time
countries already possessed a
livestock diseases, such as East
and resources and helps to ensure
recognised registration system
Coast Fever and Newcastle disease,
drug quality, safety and efďŹ cacy.
(Kenya, Tanzania and Uganda).
to name just a few, are a major
In 2011, a GALVmed initiative
Participants were asked what would
constraint to increasing smallholder
'Harmonisation of Registration
be needed to achieve a harmonised
incomes and enhancing agricultural
Requirements for Veterinary
system for registering veterinary
development, food security and
Immunologicals and Development of
vaccines and it was concluded that
resilience. Accessibility and
a Mutual Recognition Procedure
the development of a set of
distribution of high quality veterinary
(MRP) in East Africa' was launched
harmonised technical documents was
medicines is therefore the best tool
to provide support in this critical
required.
to combat animal diseases and help
area. The enterprise was undertaken
As a result of the workshop, a
curb economic losses.
to assist the East African Community
technical working group (TWG) was
(EAC) in harmonising registration
formed consisting of participants from
Cross-country registration of
requirements in the established
the national regulatory authorities of
veterinary medicines
regulatory authorities and
Kenya, Tanzania and Uganda.
Registering veterinary medicines in
strengthening their veterinary
Burundi, Rwanda and the EAC
Africa through the currently
vaccine regulatory systems.
Secretariat are also members of the
established processes is cumbersome
GALVmed's work commenced with a
TWG whose role was to work on and
and time consuming, requiring
workshop in Nairobi, involving
develop the following registration
considerable technical information
regulators from eight East African
documents: a harmonised application
September - October 2016
[28] FARMERS REVIEW AFRICA
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