FDA发布：BA和BE留样量的合规政策

未译，官网下载：https://www.fda.gov/media/141218/download

FDA publishes guidance for industry: Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR320.38(c) 
FDA发布行业指南：根据21CFR 320.38（c）BA和BE留样量的合规政策

On August 18, 2020, the FDA published the guidance for industry entitled “Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c).” This guidance describes FDA’s compliance policy related to the retention of reserve samples of the test article and reference standard used in an in vivo bioavailability (BA) and in vivo or in vitro bioequivalence (BE) study. This guidance applies only to the requirements for retention of reserve samples contained in 21 CFR 320.38(c).
2020年8月18日，FDA公布了题为“根据21 CFR 320.38（c）BA和BE留样量的合规政策”的行业指南。本指南描述了FDA体内生物利用度（BA）和体内或体外生物等效性（BE）研究中使用的测试样品和参比制剂的留样有关的合规政策。本指南仅适用于21 CFR 320.38（c）中留样的要求。
FDA has determined that, with technological advances, generally, a reduced quantity of reserve samples than the quantity set forth in the regulation is now sufficient for FDA testing provided that the applicant retains the minimum quantity deemed by FDA to be sufficient for conducting the necessary chemical and physical examination of the samples to assure the identity and composition of the test article and reference standardas intended by the regulation. Accordingly, at this time and based on our current understanding of the risks involved, FDA does not intend to enforce the requirement to retain a sufficient quantity to perform five times all the release tests required in the application or supplemental application, so longas the identified lower quantities are retained.  This reduced quantity will provide a less burdensome approach for applicants and CROs but remains consistent with our mission to ensure public health.
FDA认为，随着技术的进步，通常留样数量少于法规中规定的数量现在足以满足FDA的检测要求，前提是申请人保留了FDA认为足以进行必要理化检测的最低数量，确保受检样品和参比样品的成分和组成比例与要求一致。因此，根据目前我们对所涉及风险的了解，FDA并不打算强制要求保留5倍申请或补充申请中要求的所有放行测试所需数量，前提是保存了所需的最低数量。减少留样量可为申报人和CRO减轻负担，但仍能确保我们履行保护公众健康的使命。
Specifically, this guidance:具体来说，本指南：
Addresses the requirement at 21 CFR320.38(c) to retain reserve samples of sufficient quantity to permit FDA to perform five times all the release tests required in an application or supplemental application; and
满足21 CFR 320.38（c）的要求，保留5倍FDA执行申报资料或补充申报资料全套放行检测项目的数量，以及

Describes the conditions under whichthe Agency does not generally intend to take regulatory action against anapplicant or contract research organization (CRO) for retaining less than the quantity of reserve samples of the test article and reference standard thatwere used in the BA or BE study specified in 21 CFR 320.38(c)

描述了在什么条件下FDA不会对申请人或合同研究组织（CRO）的受检样品和参比样品留样少于21 CFR 320.38(c)中所要求的BA或BE留样数量时采取监管措施

This guidance does not apply to theother requirements for retention of reserve samples contained in 21 CFR 320.38,such as how testing facilities must select samples for testing, how the reservesamples must be retained, and whether reserve samples are in fact representative of the test article and reference standard used in the BA or BE study. Additionally, this guidance does not affect the requirement in 21 CFR 211.170 to retain samples under current good manufacturing practices.
本指南不适用于21 CFR 320.38中其它留样要求，例如测试设施必须如何选择要测试的样品，留样要如何保存，留样是否代表BA或BE研究中的受测样品和参比样品。另外，本指南并不会影响21 CFR 211.170中CGMP对留样的要求。
Although this guidance document is immediately in effect, it remains subject to comment in accordance with FDA good guidance practices regulation and FDA will consider all comments receivedand revise the guidance document as appropriate (see 21 CFR 10.115(g)(3)). You may submit either electronic or written comments on this guidance at any timevia www.regulations.gov.
虽然本指南立即生效，但仍需根据FDA的GGP征求意见，并且FDA将考虑收到的所有意见对指导文件进行适当修改（请参阅21 CFR 10.115（g）（3））。建议和意见提交途径www.regulations.gov。

       文章来源：允咨GMP制药技术

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