Recognition of Alternative Compendia (BP/EP/JP) by the FDA

The Office of Pharmaceutical Quality within FDA's Center for Drug Evaluation and Research (CDER) published a new edition of the document "MAPP (Manual of Policies and Procedures) 5310.7 - Acceptability of Standards from Alternative Compendia (BP/EP/JP) on 30 January 2017. The main change to the previous version from 2007 lies in the fact that the document is now published by the "Office of Pharmaceutical Quality". There were no substantial changes in the content. Nevertheless, as this FDA document is often unknown among the pharmaceutical industry, the most important contents are listed here again. It is particularly interesting for all those who work in the areas of marketing authorisation or incoming goods control in the pharmaceutical industry.

The background to this is that it is not uncommon in the authorisation of medicinal products in the USA that applicants propose monographs from the British Pharmacopoeia (BP), the European Pharmacopoeia (EP) or the Japanese Pharmacopoeia (JP) as quality standards (monographs) for the excipients and APIs in their applications. Yet, because the United States Pharmacopeia/National Formulary (USP/NF) is the drug compendium officially recognized in the United States, FDA reviewers have been very reluctant so far to recognize BP, EP, or JP quality standards and methods as part of the drug application review process, even when a monograph from those pharmacopoeias is equivalent to or even better than the corresponding USP/NF standards. Moreover, in the past U.S. reviewers gave different advice about that topic.

FDA's document MAPP 5310.7 states:

"It is reasonable to accept an applicant's proposal to use a quality standard from the BP, EP, or JP as part of the specifications for an excipient, drug substance, or drug product in the drug application, if the standard in the BP, EP, or JP is equivalent to or better than the corresponding standard in the USP/NF. Equivalent standards have the same acceptance criteria and make use of analytical procedures based on similar principles (e.g., chromatographic, spectroscopic, titration) and performance characteristics (e.g., specificity, accuracy, precision). A standard can be considered better than a corresponding standard for a number of reasons, including narrower ranges for acceptance criteria or superior performance of the analytical procedure (e.g., improved specificity, greater accuracy)."

Those regulations apply to the product assessments of new drug applications proceeded by the CDER/OPQ (Office of Pharmaceutical Quality).

This flexibility of the U.S. American authorisation and monitoring authority is very welcome for the pharmaceutical industry.

To get more information please access the full document of the FDA MAPS 5310.7 "Acceptability of Standards from Alternative Compendia (BP/EP/JP)".