美国FDA 指导原则 活体生物治疗产品的早期临床试验工业用化学制造和控制信息指南 英文原版.pdf

Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information Guidance for Industry This guidance is for immediate implementation FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(3) without seeking additional comments after determining that prior public participation is not reasonable or appropriate (see 21 CFR 10.115(g)(2)). FDA notes that we already sought comments on the issues addressed by the revisions in this guidance in the Federal Register notice of March 31, 2015 (80 FR 17050) entitled “Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry: Request for Comments,” under Docket No. FDA-2010-D-0500. Further delay in implementing these revisions could impede the progress of certain investigations that are of low risk and may be of benefit to the public health. FDA invites comments on this guidance. Submit one set of either electronic or written comments on this guidance at anytime. Submit electronic comments to . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You should identify all comments with docket number FDA-2010-D-0500. Additional copies of this guidance are available from the Office of Communication, Outreach and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-8010, or email ocod@, or from the Internet at /BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida nces/default.htm. For questions on the content of this guidance, contact OCOD at the phone numbers or email address listed above. U.S. Depa