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GUIDANCE DOCUMENT

E17 General Principles for Planning and Design of Multi-Regional Clinical Trials July 2018

Final

E17 General Principles for Planning and Design of Multi-Regional Clinical Trials

Docket Number:
2018-15395
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

With the increasing globalization of drug development, it has become important that data from
multiregional clinical trials (MRCTs) can be accepted by regulatory authorities across regions and
countries as the primary source of evidence to support marketing approval of drugs (medicinal
products). The purpose of this guidance is to describe general principles for the planning and
design of MRCTs with the aim of increasing the acceptability of MRCTs in global regulatory
submissions. 
 


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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:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2018-15395.