FDA发布Q3B(R2)新药产品杂质最终指南及其第二次修订
Q3B(R2) Impurities in New Drug Products
FDA发布Q3B(R2)《新药产品杂质》最终指南，就化学合成新原料药所制新药产品的注册申请提出杂质含量与界定建议。该指南修订1997年5月发布的同名ICH指南，并在2003年2月首次修订后作出第二次修订，本次主要澄清附件2。指南与ICH Q3A(R)互补，必要时可参考ICH Q3C。
文件说明该杂质指南的第二次修订主要澄清附件2，并交代其与Q3A(R)、Q3C等ICH指南的衔接关系。
GUIDANCE DOCUMENT
Final Level 2 Revised Guidance
- Docket Number:
- FDA-1996-D-0048 (Revision 1)
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
This guidance provides recommendations for registration applications on the content and qualification of impurities in new drug products produced from chemically synthesized new drug substances not previously registered in a region or member state. This guidance revises the ICH guidance of the same title that was issued in May 1997 and first revised in February 2003. The first revision clarified the 1997 guidance and included other changes. The revision also provided consistency with more recently published ICH guidances (e.g., Q3A(R) Impurities in New Drug Substances, Q3C Impurities: Residual Solvents, and Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances). This second revision provides clarification to Attachment 2. This guidance complements the ICH Q3A(R) guidance, which should be consulted for basic principles along with ICH Q3C when appropriate.
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-1996-D-0048 (Revision 1) .
来源：FDA Pharmaceutical Quality Documents · fda.gov