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Why
IPEC-Americas Is Needed:
Under U.S. law, a new pharmaceutical excipient, unlike an active
drug, has no regulatory status unless it can be qualified through
one or more of the three approval mechanisms available for components
used in finished drug dosage forms, e.g.:
- GRAS determination pursuant
to 21 CFR 182, 184, and 186;
- approval of a food additive
petition in 21 CFR 171; and
- as contained in an NDA
approval for a specific drug product and for a particular function
or use in that dosage form.
All three mechanisms are
time consuming, inordinately expensive, and have become increasingly
complex in recent years. None has a formal safety evaluation
process or suitable approval process specifically for excipients.
In addition, varying national drug registration or approval systems
and differences in excipient monograph specifications among the
three major pharmacopoeias, the PhEur, JP, and USP make it virtually
impossible to produce a single finished drug formulation that
can be marketed on a global basis.
This situation is unlikely to change until:
- National drug approval
systems are expanded to permit reasonable procedures for acceptance
of new excipients and new excipient uses;
- An appropriate system
exists for qualifying excipient suppliers and their products;
- Harmonization of compendial
standards for more widely used pharmaceutical excipients is achieved
among the major pharmacopoeias; and
- There is mutual recognition
and mutual acceptance of pharmaceutical safety and effectiveness
data from other national systems among the industrialized countries.
These, as noted earlier in the IPEC-Americas Mission Statement, are major Council goals
.
For more information
on IPEC...
...and to learn more about how your company can benefit by joining IPEC-Americas, you are invited to contact:
info@ipecamericas.org
Mailing Address:
IPEC-AMERICAS
1655 North Fort Myer Drive, Suite 700
Arlington, VA 22209
Tel: (703) 875-2127
Fax: (703) 525-5157
9/26/02
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