31 August - 3 September 2021
The FDA Does Recognise Alternative Compendia (BP/EP/JP) After All
This document is of great interest to all those in the pharmaceutical industry who are involved in regulatory affairs or the inspection of incoming goods.
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 (monographs) 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 now published FDA document MAPP (Manual of Policies and Procedures) 5310.7 of 3 November 2007 says among others:
It is reasonable to accept an applicants 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).
These regulations concern the CMC evaluation of applications for marketing authorisations of medicinal products conducted by CDER/OPS/Office of New Drug Quality Assessment.
The FDA writes that it does not intend to establish BP, EP and/or JP as official compendia in addition to or as a replacement for the USP.
This new flexibility of the American registration and supervisory authority
represents a surprising and independent step towards harmonisation and will be
greatly welcomed by the pharmaceutical industry.