Zdrowie i gospodarka · 31/07/1997

International Conference on Harmonisation; Draft Guideline on Ethnic Factors in the Acceptability of Foreign Clinical Data; Availability

The Food and Drug Administration (FDA) is publishing a draft guideline entitled ``Ethnic Factors in the Acceptability of Foreign Clinical Data.'' The draft guideline was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guideline provides guidance on regulatory and development strategies to permit clinical data collected in one region to be used for the support of drug and biologic registrations in another region while allowing for the influence of ethnic factors.