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[e-drug] Philippines Generics law (cont'd)

  • From: Jody Dalmacion <jrvd1953@yahoo.com>
  • Date: Mon, 28 Feb 2000 09:55:49 -0500 (EST)

E-drug: Philippines Generics law (cont'd)

Dear Dr. Roy,

I'm afraid there has been no formal endeavor to study how much cost
goes into analysis, validation and stability testing of generic drugs.
However,these are all required by our Bureau of Food and Drug
Administration before generic drugs can obtain a certificate of
registration. How much of this cost is passed on to the consumer is
something I myself have not studied. Among the validation for
equivalence it is the test of bioequivalence that cost the most both in
terms of direct cost (1997-about $21,250 using at most 14 to 16
subjects) and indirect cost by using normal volunteers. Presently, I sit
in the National Bioavailability Advisory Board which aids the regulatory
agency in the accreditation of institutions or agencies who would like
to perform bioavailability/bioequivalence studies for the pharmaceutical
companies. Nevertheless, we are moving for the adaptation of the
WHO recommendation that data originating from reputable drug
companies who have met international standards for drug testing
should be acceptable to the local regulatory agency. This is to prevent
the unnecessary repetition of expensive procedures like bioequivalence
study. However, stability test in my opinion must be repeated with the
drug sample because humidity and temperature can be very different
between the place of origin and the place where it is intended to be

I hope I was able to provide you with some of the information that
you need.

Jody Vergeire-Dalmacion,MD
Assoc Prof, Dept. of Pharmacology
UP College of Medicine
Tel and fax no: 0632 521 8251
e-mail: jrvd1953@yahoo.com

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