E-DRUG: RFI: Bioequivalence and generics registration (6)
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Dear partners':
I just want to remark Andy's considerations of this topic remembering one
thing: if you do not assure GMP, no bioequivalence test is usefull. Results
will be valid only, in the best condition, for one specific batch. Not for
the others.
In the other hand, there is an irritant effort by USA and (lees intense) EU
pressing developing countries to generalize the bioequivalence (in vivo)
test exigency for generics. In fact, they are using quality assurance
issues against generics. Maybe e-druggers remember FDC and WHO
prequalification issues.
From a technical perspective, in vivo Bio tests can be considered a
generalized exigence with some exceptions. IV and IM products. Solutions for
oral dosage forms. Products with a wide therapeutic window. Such a list of
products maybe represent more than hlaf of total market? Maybe 80%?
From other perspective one can considerer Biotest an excepcional test in
very clear and well defined cases. Products with narrow therapeutic window
and evidence of absortion problems. Oral dossage forms of course. It means:
Biotests are the exception, not the rule. It is important to remember that
Bio tests are applied to human beings with ethical considerations of
Helsinki declaration. If these tests are not umprescindable, it must not be
done at alll.
Argentina, Chile and Colombia, as far as I know, defined a short list of
products (less than 20, chronic use) where Biotests are compulsory for
generic's registration. And are applying GMP. Generalized exigence of GMP.
Thanks
Francisco A. Rossi. B.
IPR and access to drugs project.
International Poverty Center.
UNDP - IPEA.
SBS. Ed BNDES, 15 andar. Sala 1513
70076-900 Brasilia D.F. Brazil.
Tel +55 61 3155415
francisco_rossi@hotmail.com
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