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Already approved and marketed products in Japan

  • 1.  Already approved and marketed products in Japan

    Posted 20-Nov-2023 13:49

    Dear Regulatory community, 

    Has anyone had the experience of working on an already approved and marketed product in Japan? and being able to market the product in US without going through all the clinical trials phases in US? 

    According to the 21CFR 314.106 it is possible to do this.  I just like to know if any one has been successful in completing an NDA/BLA only with the foreign data? 

    § 314.106 Foreign data.
    [50 FR 7493, Feb. 22, 1985, as amended at 55 FR 11580, Mar. 29, 1990]
    This content is from the eCFR and is authoritative but unofficial.
    (a) General. The acceptance of foreign data in an application generally is governed by § 312.120 of this
    (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 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.

    I appreciate the input. 

    Bani Tchekanova
    Escondido CA
    United States