When Can Drugmakers Cite Quality Standards From Foreign Compendia? FDA Explains

Posted 27 January 2017 By Zachary Brennan

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An updated Manual of Policies and Procedures (MAPP) for the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) lays out when drug sponsors and applicants can propose specifications for excipients, drug substances and drug products in their applications based on quality standards in the British Pharmacopoeia (BP), the European Pharmacopoeia (EP) or the Japanese Pharmacopoeia (JP).

Updated from 2007 and 2014 versions, the MAPP says that such citations of foreign pharmacopoeia are reasonable “if the standard in the BP, EP, or JP is equivalent to or better than the corresponding standard in the USP/NF [US Pharmacopeia/National Formulary].

“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),” it says.

The same applies if there is no USP/NF monograph for an excipient, drug substance or drug product, and the applicant proposes to use an analytical procedure from the BP, EP or JP.

“It is the responsibility of the applicant to justify the use of a standard from the BP, EP, or JP in lieu of the USP/NF standard in the application. The applicant should also provide a copy of the referenced BP, EP, or JP monograph or analytical procedure and a statement acknowledging the corresponding USP/NF monograph as the official standard or the corresponding analytical procedure as the regulatory analytical procedure," FDA says.

As far as concluding that a proposed specification is equivalent to or better than the corresponding US standard, the MAPP says OPQ product quality reviewers will make that assessment.

Office of Pharmaceutical Quality Acceptability of Standards from Alternative Compendia (BP/EP/JP)

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