E-DRUG: RFI: Bioequivalence and generics registration
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Dear E-drug Colleagues,
I have a difficult issue to handle, and I hope some of you might give
your opinion on this!
I'm a Pharmacist, working at this moment for an well known ONG
together with a local National Department of Pharmaceutical Affairs in a
third world country on the implementation of a good registration-program
for drugs. Right now I prefer to stay anonymous, since some of my
colleagues at the Department as well as at the pharmaceutical industries
are E-druggers as well...
At this moment I am facing a HUGE problem. And that's the registration
of generics. The Department has set out policy-guidelines that demands
for clinical information of each generic to be registred. This includes
the following information:
Bioequivalence of the generic to the branded version:
1) Dissolution Time in vitro;
2) Quantative analysis of the active ingredients;
3) T1/2 (Half-life) of the drug in VIVO.
In our opinion points 1 and 2 are worldwide accepted as being
"sufficient", information about bioequivalence, also according to the
U.S.P. and B.P.
Point 3 is too big problem to tackle for a thirdworld-country.
And as far as I know, no clinical information about a generics
half-life is needed for registration in most other countries. And
neither clinical-studies to identify the halflife in vivo for generics
are conducted.
Of course things always could be better... I am aware of that.
Unfortunately the National Department of Pharmaceutical affairs insists
on point 3 as a requirement for the registration of generics.
Please would you be so kind to give me your opinion on this, and some
information on other countries policy regarding requirements for the
prove of bioequivalence as part of the registration-process?
I truly hope to get some feedback!
Best regards and thanks in advance.
Anonymous
[name & address known to E-drug moderator; suggestions can be sent to
e-drug@healthnet.org]
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