definiens: or means Good Clinical Practice as promulgated by the FDA under and in accordance with the FD&C Act ( Title 21 of the U.S. Code, Section 301 et seq . ), Title 21, Parts 312 of the U.S. Code of Federal Regulations, and the guidelines and stand ards published by the FDA that relate thereto as may be amended from time to time, or any successors thereto . To the extent consistent with U.S. law, also includes the practices and standards described in the Guidelines on Principles of Good Clinical Practice in Conduct of EU Clinical Trials as promulgated by the European Commission under European Directive 2001/20 / EC and the ICH Harmonised Tripartite Guideline for Good Clinical Practice ( ICH E6 ) and any analogous practices, standards guidelines and r egulations promulgated by any applicable Regulatory Authority in any country or jurisdiction in the Territory, as each may be amended from time to time, or any successors thereto