FDA发布可比性方案最终指南，适用于NDA、ANDA和BLA的CMC上市后变更
Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA
FDA发布最终指南，帮助NDA、ANDA和BLA的原始申请人及已批准申请持有人通过可比性方案实施CMC上市后变更。指南将可比性方案定义为前瞻性撰写的综合计划，用于评估拟议的上市后CMC变更对产品鉴别、含量、质量、纯度、效力的影响。文件编号FDA-2016-D-0973，由CBER与CDER发布，公众可随时提交意见。
最终指南界定了可比性方案在评估上市后CMC变更对产品质量影响中的用途，并明确适用申请类型。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2016-D-0973
- Issued by:
-
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
This final guidance is intended to assist original applicants and holders of approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) with implementing a chemistry, manufacturing, and controls (CMC) postapproval change through the use of a comparability protocol (CP). A CP is a comprehensive, prospectively written plan for assessing the effect of a proposed postapproval CMC change(s) on the identity, strength, quality, purity, and potency of a drug product, including a biological product (i.e., product), as these factors may relate to the safety or effectiveness of the product (i.e., product quality).
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-2016-D-0973.
来源：FDA Pharmaceutical Quality Documents · fda.gov