E-DRUG: Drug Quality Assessment
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Dear Fitsumbirhan,
I noted your enquiry with interest. It is not clear from your
communication whether you have a drug registration system in place or
not. In Kenya when we are dealing with new products being applied for and we
know from the WHO guidelines on registration of multi-source products
(generics) that there is likely to be a problem, we ask them to
provide dissolution data so that we can assess the performance of the
product prior to giving the marketing authorization. This may come
from the monograph specified on the label or if there is no
dissolution monograph and one is specified in the USP for example, we
indicate that we expect the product to pass the dissolution
requirements for the product in the USP.
I think that as the regulatory authority you should use all technical
means at your disposal to deal with problem products. It is within
your mandate to specify other tests that in your opinion will give an
indication as to the performance of the product. It is something that
we have done on a number of occasions. If you need any assistance
with independent testing of the offending products for a second
opinion, we would be happy to assist.
Sincerely
Dr. Elizabeth Ominde-Ogaja
Director
National Quality Control Laboratory
P.O. Box 29726
Nairobi
Kenya
Fax: +254-2-718073
Tel: +254-2-726963
email: afdran-nqcl@ken.healthnet.org or natqclab@net2000ke.com
(direct)
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