FDA 发布 Q4B 药典文本评估与推荐最终指南（FDA-2008-D-0081）
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
FDA 发布 Q4B 药典文本评估与推荐最终指南，文件编号 FDA-2008-D-0081，由 CDER 与 CBER 发布。文件说明 Q4B 专家工作组评估选定药典文本、推动其在 ICH 地区被监管机构认可为可互换使用的流程。评估结果良好后 ICH 将发布主题附录说明这些文本及其实施，Q4B 附录的实施意在避免行业重复检测。
该最终指南梳理 Q4B 专家工作组评估药典文本、推动其在 ICH 地区互认的流程及后续附录安排。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2008-D-0081
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
This document describes a process for the evaluation and recommendation by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Following favorable evaluations, ICH will issue topic-specific annexes with information about these texts and their implementation (the Q4B Outcomes). Implementation of the Q4B annexes is intended to avoid redundant testing by industry.
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-2008-D-0081.
来源：FDA Pharmaceutical Quality Documents · fda.gov