FDA发布Q3A新原料药中的杂质最终指南
Q3A Impurities in New Drug Substances
FDA发布Q3A《新原料药中的杂质》最终指南，适用于化学合成、且未在某一地区或成员国注册过的新原料药的注册申报。文件针对杂质的含量与界定给出指导，并说明可通过卷宗编号FDA-2013-S-0610提交意见。
该最终指南说明化学合成新原料药的杂质含量与界定要求，可用于注册申报时对照其适用范围。
GUIDANCE DOCUMENT
Final
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
This document is intended to provide guidance for registration applications on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a region or member state.
Submit Comments
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
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 comments should be identified with the title of the guidance.
来源：FDA Pharmaceutical Quality Documents · fda.gov