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At the end of February, the Office of New Drug Quality Assessment (ONDQA)
within the Center for
Drug Evaluation and Research (CDER) of FDA published a highly interesting
document, which was of great importance to all those involved in
registration or incoming goods control.
The back story was that, when applying for a marketing
authorisation in the US, it is not unusual for registrants to suggest
monographs of the British Pharmacopoeia (BP), the European Pharmacopoeia
(EP) or the Japanese Pharmacopoeia (JP) as quality standards
(specifications) for active pharmaceutical ingredients or excipients.
However, since the US Pharmacopoeia (USP/NF) represents the official
compendium in the US, the FDA reviewers had been very reluctant to recognise
BP, EP or JP standards and methods as part of the application, even if a
monograph from these pharmacopoeias was equivalent or superior to a USP/NF
monograph. And in the past, FDA reviewers also gave different advice on this
topic.
The core statement of the FDA document MAPP (Manual of Policies
and Procedures) 5310.7 <Acceptability of Alternative Compendia (BP/EP/JP)>
published in February 2007 was:
It is reasonable to accept an applicant's proposal to use a specification (attribute, analytical
procedure, and acceptance criteria) for a drug substance or excipient in a BP, EP, or JP
monograph as part of the specifications in the drug application, if the analytical procedure and
acceptance criteria in the BP, EP, or JP monograph are equivalent or superior to the analytical
procedure and acceptance criteria in the corresponding USP/NF monograph.
These regulations would have referred to the CMC assessment of
applications for the marketing authorisation of a medicinal product conducted by
the CDER/OPS/Office of New Drug Quality Assessment.
In the meantime, this document has been withdrawn. The
original hyperlink just leads to the message "Discontinued/withdrawn
or obsolete MAPP". The reasons for the withdrawal have not yet been
explained.
Since the FDA actively supports the harmonisation, it is to be
hoped that the document will be published again with the same or a similar
wording.
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