E-DRUG: E-DRUG Veterinary Medicines

["Dr Ian Roberts" <irobmoh@global.co.za>]

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E-DRUG Veterinary Medicines

As most e-drug participants are aware we are at present, in South Africa,
restructuring our medicines regulatory body with the intention of having a
Medicines Regulatory Authority which is comparable to the best in the world.
To do this we are looking at many systems and processes which exist
internationally which may be different to ours here and may add value if we
adopt them.

I should be most grateful to receive some information from other countries
with respect to the registration of veterinary products especially if the
regulatory authority or other stakeholders in the process believe that the
system is efficient and productive.

To the best of my knowledge, currently in South Africa, it appears that
veterinary medicines fall under two Acts.  One a Health Act the other an
Agriculture Act.  This means that some vet products are licensed by the
Medicines Control Council.  However it also appears that medicines can be
added to stockfeeds and these medicines are not regulated by the MCC.

Is this common practice elsewhere and is it desirable?

Are any additional pre-clinical  data required for the registration of
veterinary medicines as opposed to human medicines.

Are the veterinary clinical trials as extensive as those required for humans
and do they have to be species specific before registration is approved.

Is it necessary to have experts in veterinary toxicology, pharmacy &
pharmacology assessing vet medicines? Or would those specialists who
regulate human medicines be as efficient for the majority of vet medicines
especially if they could outsource specific areas which are complicated?

Thanking you all

Dr Ian Roberts
Special Advisor to the Minister of Health



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