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;beginning with how they are produced through recognized good manufacturing practices standards;
- 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 in the IPEC-Americas Mission Statement, are major Council goals.