FDA Withdraws Recognition of Alternative Pharmacopoeias (BP/EP/JP)

GMP News
9 May 2007

FDA Withdraws Recognition of Alternative Pharmacopoeias (BP/EP/JP)

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In the meantime, this document has been withdrawn. The original hyperlink just leads to the message "Discontinued/withdrawn or obsolete MAPP".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.

The pharmacopoeial requirements on APIs and excipients are among the central topics of the GMP Education Course "Quality Control of Raw Materials" to be held in Prague, Czech Republic, on 16 and 17 October 2007.

Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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