FDA对替代药典（BP/EP/JP）的认同

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

FDA对替代药典（BP/EP/JP）的认同

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.

2017年1月30日FDA的CDER药品质量办公室发布了新版的MAPP（政策和程序手册）5310.7—替代药典（BP/EP/JP）标准可接受性。与2007年的前版本相比，主要变更在于现在文件是由“药品质量办公室”发布。在内容方面则没有重大变化。当然，由于该FDA文件在制药行业并不出名，最重要的内容在此重新列了一下。在MA领域工作的人们，或者是从事药品行业进厂产品控制的人们应该会有兴趣。

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.

其发布背景是在美国的药品上市中并不常见申报人提请使用BP、EP或JP各论作为其申报中原料药和辅料的质量标准。当然，因为USP/NF是美国官方认可的药典，FDA审核人员截止目前还是很不情愿认同EP、EP或JP质量标准和方法作为药品申报审核过程的一部分，即使是这些药典的各论等同甚至优于对应的USP/NF标准。还有，在过去，美国审核人员会对这些问题给出不同的建议。

FDA's document MAPP 5310.7 states:

FDA的文件MAPP 5310.7声明：

"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)."

“如果BP、EP或JP的标准等同或优于相应的USP/NF标准，那么接受申报人在药品申报资料中提议使用EP、EP或JP作为某种辅料、药用物质或药品的质量标准的部分是合理的。等同标准具有相同的可接受标准，使用依据类似的原理（例如色谱、分光法、滴定法）和性能特征（如专属性、准确度和精密度）的分析方法。有大量的理由可以认为该标准是优于相应的标准，包括，更窄的可接受标准范围，或更优的分析方法性能（例如，改善专属性，更加准确）。”

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

这些规定适用于CDER/OPQ（药品质量办公室）新药申报药品审评程序。

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

美国药品批准和监控机构的灵活性非常受到制药行业的欢迎。

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

更多信息，参见FDA全文。

感谢楼主分享，辛苦