FDA发布BPCI法案视为许可条款问答最终指南
The "Deemed to be a License" Provision of the BPCI Act: Questions and Answers
FDA发布《BPCI法案视为许可条款：问答》最终指南，以问答形式说明该过渡条款的实施。按指南所述，截至2020年3月23日依据FD&C法案第505条获批的生物制品申请，将在当日被视为PHS法案第351条下的生物制品许可。指南还说明了被视为生物制品许可申请（BLA）相关产品的标签合规政策。
指南以问答形式梳理BPCI法案过渡条款的实施安排，并说明被视为BLA产品的标签合规政策，便于读者把握过渡日节点。
GUIDANCE DOCUMENT
The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers Guidance for Industry March 2020
Final Level 1 Guidance
- Docket Number:
- FDA-2015-D-4750.
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research, Office of Regulatory Policy
Center for Biologics Evaluation and Research
This guidance is intended to provide answers to common questions about FDA’s implementation of the “transition” provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) under which an application for a biological product approved under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355) as of March 23, 2020, will be deemed to be a license for the biological product under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262) on March 23, 2020 (the transition date). This guidance also describes FDA’s compliance policy for the labeling of biological products that are the subject of deemed biologics license applications (BLAs). This guidance is intended to facilitate planning for the transition date and provide further clarity regarding the Agency’s implementation of this statutory provision.
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-2015-D-4750. .
来源：FDA Pharmaceutical Quality Documents · fda.gov