definiens: means the then current good manufa cturing practices, standards, guidelines and regulations promulgated and published by the FDA, E uropean Commission and/or the European Medicines Agency relating to the testing, manufacturing, proc essing, packaging, labelling, holding or distributi on of biologics, drug substances, human cells, tissues, a nd cellular or tissue - based products, and/or finish ed drugs, to the extent applicable to the Services, including an y standards, guidelines and regulations as promulga ted by : ( i ) the FDA under and in accordance with the U.S. Feder al Food, Drug and Cosmetic Act, Title 21, Parts 210, 211, 600, 610, and 1271 of the U.S. Code of Federal Regu lations and the Public Health Service Act, to the e xtent applicable ; and/or ( ii ) the European Medicines Agen cy, EU Commission and EU member state governmental authorities under and in accordance with European D irective 2003/94 / EC, including, in each case of ( i ) and ( ii ), the ICH Harmonised Tripartite Good Manufacturing Pr actice Guide to the extent it, or components thereo f, are adopted by the FDA and/or the European Medicines Ag ency