Botanical Drug development2015FDA植物药研发行业指南（草案）（中英对译稿）

Contains Nonbinding Recommendations

Draft — Not for Implementation 包含不具约束力的建议 草案 — 不用于实施

Botanical Drug Development

Guidance for Industry

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document contact (CDER) Sau L. Lee at sau.lee@fda.hhs.gov 301-796-2905, or Rajiv Agarwal at rajiv.agarwal@fda.hhs.gov 301-796-1322.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

August 2015

Pharmaceutical Quality/CMC

Revision 1

北京大学药物信息与工程研究中心?comments@cpier.pku.edu.cn?

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Contains Nonbinding Recommendations

Draft — Not for Implementation 包含不具约束力的建议 草案 — 不用于实施

植物药研发

行业指南

指南草案

本指南发布仅用于征询意见目的。

涉及本指南文件的意见和建议应在联邦公告通告公布本指南草案的60日内提交涉及本指南文件的意见和建议。电子版意见、建议请提交至http://www.regulations.gov。书面意见、建议提交至the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.。所有意见、建议应标明联邦公告公布通告中所列出的卷宗号。

与本指南相关的问题，请致电301-796-2905或发送电子邮件sau.lee@fda.hhs.gov垂询药品审评与研究中心Sau L. Lee，或致电301-796-1322或发送电子邮件rajiv.agarwal@fda.hhs.gov垂询Rajiv Agarwal。

美国卫生与人类服务部

食品药品管理局

药品审评与研究中心（CDER）

制药质量/化学、制造、控制（CMC）

修订版1

北京大学药物信息与工程研究中心?comments@cpier.pku.edu.cn?

?ii?

?

Contains Nonbinding Recommendations

Draft — Not for Implementation 包含不具约束力的建议 草案 — 不用于实施

Botanical Drug Development

Guidance for Industry

Additional copies are available from:

Office of Communications, Division of Drug Information

Center for Drug Evaluation and Research

Food and Drug Administration

10001 New Hampshire Ave., Hillandale Bldg., 4th Floor

Silver Spring, MD 20993

Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353

Email: druginfo@fda.hhs.gov

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

August 2015

Pharmaceutical Quality/CMC

Revision 1

北京大学药物信息与工程研究中心?comments@cpier.pku.edu.cn?

?iii?

?

Contains Nonbinding Recommendations

Draft — Not for Implementation 包含不具约束力的建议 草案 — 不用于实施

植物药研发

行业指南

另外的副本可从以下部门得到：

马里兰州银泉市新罕布什尔大道10001号Hillandale 楼4层 药品信息处，对外信息办公室，

邮政编码：20993

电话：855-543-3784或301-796-3400; 传真：301-431-6353

电子邮件：druginfo@fda.hhs.gov

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

美国卫生与人类服务部

食品药品管理局

药物评估和研究中心（CDER）

2015年8月

制药质量/化学、制造、控制（CMC）

修订版 1

北京大学药物信息与工程研究中心?comments@cpier.pku.edu.cn?

?iv?

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