FDA_替代药典标准可接受性 （BP/EP/JP）

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2017年9月20日FDA的药品质量办公室 (Office of Pharmaceutical Quality) 发布了MAPP（政策和程序手册）修订版 5310.7 Rev 1 - 替代药典标准可接受性（BP/EP/JP） (Acceptability of Standards from Alternative Compendia)。


PURPOSE
• This MAPP provides clarification to Office of Pharmaceutical Quality (OPQ) reviewers on the appropriate use of quality standards for excipients, drug substances, and drug products found in alternative compendia, specifically the British Pharmacopoeia (BP), the European Pharmacopoeia (EP), and the Japanese Pharmacopoeia (JP), during chemistry, manufacturing, and controls (CMC) review of drug applications (i.e., investigational new drug applications (INDs), new drug applications (NDAs), and abbreviated new drug applications (ANDAs)).
• This MAPP is not intended to establish the BP, EP, and/or JP as official compendia in place of or in addition to the United States Pharmacopeia/National Formulary (USP/NF).
• This MAPP is not intended to preclude any current efforts to establish a process for evaluation and regulatory acceptance of harmonized analytical procedures and/or acceptance criteria.

目的:

• MAPP向药品质量部门（OPQ）评审员提供了关于适当使用辅料，原料药和药品的质量标准在替代药典中特定的英国药典（BP），欧洲药典（EP）和 日本药典（JP）在化学，制造和控制（CMC）审查药物申请（即研究药新药申报（INDs），新药申报（NDAs）和仿制药申报（ANDAs））期间。
• MAPP不打算将BP，EP和/或JP作为官方公式来代替或补充美国药典/国家处方集(USP / NF)。
• MAPP不旨在排除目前的努力，以建立评估和监管接受协调分析程序和/或验收标准的过程。
  

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).

“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）。”

这MAPP在2017年10月4日起生效。

胜利者

顶起

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