FDA 发布批准后原料药变更指南草案并开放征求意见

Postapproval Changes to Drug Substances

AI 导读

FDA 发布批准后原料药变更指南草案，面向已批准 NDA、ANDA、NADA、ANADA 持有人以及 DMF、VMF 持有人，针对其在药品申请批准后阶段变更原料药生产工艺。该草案明确不涉及 BLA 持有人或 BLA 中引用的任何主文件。文件为草案、不供实施，注明可按文档号 FDA-2018-D-3151 提交意见。

推荐理由

草案界定了批准后原料药生产变更适用与不适用的申请类型，便于读者对照自身申报类别定位范围。

正文 · 原文

GUIDANCE DOCUMENT

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:

FDA-2018-D-3151

Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

Center for Biologics Evaluation and Research

Center for Veterinary Medicine

This guidance provides recommendations to holders of approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), new animal drug applications (NADAs), and abbreviated new animal drug applications (ANADAs) and holders of drug master files (DMFs) and veterinary master files (VMFs) who want to make a change to the drug substance manufacturing process during the drug product application’s postapproval period. It does not address holders of biologics license applications (BLAs) or holders of any master files cross-referenced in BLAs.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-3151.