[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.106]

[Page 132-133]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG--Table of Contents
 
   Subpart D--FDA Action on Applications and Abbreviated Applications
 
Sec. 314.106  Foreign data.

    (a) General. The acceptance of foreign data in an application 
generally is governed by Sec. 312.120 of this chapter.
    (b) As sole basis for marketing approval. An application based 
solely on foreign clinical data meeting U.S. criteria for marketing 
approval may be approved if: (1) The foreign data are applicable to the 
U.S. population and U.S. medical practice; (2) the studies have been 
performed by clinical investigators of recognized competence; and (3) 
the

[[Page 133]]

data may be considered valid without the need for an on-site inspection 
by FDA or, if FDA considers such an inspection to be necessary, FDA is 
able to validate the data through an on-site inspection or other 
appropriate means. Failure of an application to meet any of these 
criteria will result in the application not being approvable based on 
the foreign data alone. FDA will apply this policy in a flexible manner 
according to the nature of the drug and the data being considered.
    (c) Consultation between FDA and applicants. Applicants are 
encouraged to meet with agency officials in a ``presubmission'' meeting 
when approval based solely on foreign data will be sought.

[50 FR 7493, Feb. 22, 1985, as amended at 55 FR 11580, Mar. 29, 1990]