FDA 发布新药申请原料药杂质最终指南，建议参照 ICH Q3A

GUIDANCE DOCUMENT

NDAs: Impurities in Drug Substances February 2000

Final

Docket Number:

FDA-1998-D-0277

Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

This guidance recommends that applicants refer to Q3A Impurities in New Drug Substances (January 4, 1996, 61 FR 371) when seeking guidance on identification, qualification, and reporting of impurities in drug substances that are not considered new drug substances. Although Q3A was developed by the International Conference on Harmonisation (ICH) to provide guidance on the information that should be provided in a new drug application (NDA) in support of impurities in new drug substances that are produced by chemical syntheses, the Agency believes that the guidance provided there on identification, qualification, and reporting of impurities should also be considered when evaluating impurities in drug substances produced by chemical syntheses that are not considered new drug substances.

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-1998-D-0277.