FDA 发布《先进制造技术认定项目》最终行业指南
Advanced Manufacturing Technologies Designation Program
FDA 宣布提供名为《先进制造技术认定项目》的最终行业指南，该指南对 2023 年 12 月 13 日发布的同名草案完成定稿。指南面向有意参与 FDA 先进制造技术认定项目的个人和组织提出相关建议，以推动使用已获认定的先进制造技术生产药物。文件编号为 FDA-2023-D-4974，公众可随时就该指南提交意见。
材料为同名草案的定稿版，可供读者对照 2023 年 12 月草案了解 FDA 对先进制造技术认定项目的建议。
GUIDANCE DOCUMENT
Final Level 1 Guidance
- Docket Number:
- FDA-2023-D-4974
- Issued by:
-
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
December 2025 FDA Report to Congress: Advanced Manufacturing Technologies Designation Program
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Advanced Manufacturing Technologies Designation Program.” FDA encourages the early adoption of advanced manufacturing technologies (AMTs) by the pharmaceutical industry, which can improve the reliability and robustness of the manufacturing process and can benefit patients by enhancing product quality and reducing drug development time or increasing or maintaining the supply of drugs that are life-supporting, life-sustaining, of critical importance to providing health care, or in shortage. This guidance provides recommendations to persons and organizations interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program, which facilitates the development of drugs manufactured using an AMT that has been designated as such under the program. The guidance finalizes the draft guidance of the same title issued on December 13, 2023.
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-2023-D-4974.
来源：FDA Pharmaceutical Quality Documents · fda.gov