FDA 发布 ICH Q12 实施考量草案指南并重新开放评论期
ICH Q12: Implementation Considerations for FDA-Regulated Products
FDA 发布《ICH Q12 实施考量》行业指南草案，说明其在 FDA 监管产品中实施 ICH Q12 的相关考虑。该文件为 1 级草案，不供实施，仅含非约束性建议，稿件编号为 FDA-2021-D-0166。FDA 另发布公告重新开放该指南的评论期，评论可随时在线或书面提交。
该草案列出 FDA 对 ICH Q12 的实施考量，并说明评论期重新开放，便于读者对照生命周期管理框架理解 FDA 的实施考虑。
GUIDANCE DOCUMENT
ICH Q12: Implementation Considerations for FDA-Regulated Products Draft Guidance for Industry May 2021
Draft Level 1 Guidance
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2021-D-0166
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
The International Council for Harmonisation (ICH) guidance for industry Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and its Annexes (ICH Q12, May 2021) provide a framework to facilitate the management of postapproval chemistry, manufacturing, and controls (CMC) changes in a more predictable and efficient manner. ICH Q12 includes regulatory tools and enablers with associated guiding principles that should enhance industry’s ability to manage postapproval changes and increase transparency between industry and regulatory authorities, supporting innovation and continual improvement.
FEDERAL REGISTER NOTICES:
- The original notice announcing availability of the guidance
- The new notice about the reopening of the comment period
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-2021-D-0166.
来源：FDA Pharmaceutical Quality Documents · fda.gov