Legal Information: Healthcare & Biomedical Law

OHRP has published a variety of guidance documents to assist the research community in conducting ethical research that is in compliance with the HHS regulations. On this page, OHRP guidance documents are organized in categories that should be intuitive for members of the research community. In addition, all guidance documents can be accessed through an alphabetical list.

A project of regulatory authorities & experts from Europe, Japan and the United States from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration and to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the R&D of new medicines.