The Regulatory and Compendial Pathways to Acceptance for AIM and EDA Concepts - Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products - page 362

apprehensions, it is therefore incumbent upon the pharmaceutical industry stake-
holders to provide convincing arguments in favor of both AIM and EDA through a
combination of open publications and, where appropriate, direct presentation to
regulators.
An important message arising from these opportunities for dialogue with regula-
tory agency representatives is that AIM and EDA do not present any major obstacles
to becoming useable techniques. Indeed, during questions at the special sympo-
sium, the FDA representatives made it clear that to have AIM as a compendial
technique would provide a useful practical approach to ensure the adoption of con-
sistent methodology across the industry. The position of the EMA representative
concerning compendial adoption was similar (see above).
Representatives from the European Pharmaceutical Aerosol Group (EPAG) pro-
vided a briefi ng to the UK Medicines and Healthcare Products Regulatory Agency
(MHRA) on the AIM concept in June 2011, at which a cautiously favorable response
was also received. The representatives from the MHRA, taking a similar position to
that voiced earlier by the FDA representatives at the IPAC-RS satellite meeting
entitled “ Perspectives on Effi cient Data Analysis and Abbreviated Impactor
Measurements as Quality Assessment Tools ” held at the Respiratory Drug Delivery
Europe 2011 conference, that the development of a robust understanding of the
relationship between full-resolution CI and AIM data for all OIP classes would be
critical to their acceptance of the AIM approach. Given the signifi cant differences in
equipment and data assessment, AIM could be considered by the MHRA as a “new
technology,” and as such the justifi cation for its adoption would have to refl ect this
standing through appropriate validation. Inclusion of AIM-based methodology in a
Ph. Eur. monograph would go a long way towards demonstrating the approach to be
valid and justifi able for use, since Ph. Eur. test methods are considered authoritative
in the case of any dispute in post-marketing surveillance. These suggestions further
highlight the importance to have AIM-based methods formalized by inclusion in the
compendia.
Within the compendial environment, both the Aerosols Subcommittee of the
USP General Chapters—Dosage Forms Expert Committee—and the Inhalanda
working group of the Ph. Eur. will need to conduct their own assessments both tech-
nically and from a quality assurance standpoint as the fi rst step towards adoption. It
is anticipated that from the start, both groups will share dialogue and move, either
formally or informally, towards “harmonized” AIM and EDA positions that lead
ultimately to harmonized monographs. The best route for this to occur would be for
AIM and later perhaps EDA to be progressed through the formal PDG harmoniza-
tion process which includes all three leading pharmacopeia (USP, Ph. Eur., and JP).
In Europe, pharmaceutical industry stakeholders can remain involved by lobbying
their respective national pharmacopeial authorities to progress this process as well
as by responding to technical articles appearing in the journals Pharmeuropa
Scientifi c Notes and draft monograph texts that are published in Pharmeuropa . In
the USA and Canada, the most effective way to remain involved will be through
responses to “ Stimuli to Revision ” articles, when they appear in the journal,
Pharmacopeial Forum , and later as draft chapters are published in this journal for
public review.