definiens: means the then - current good manufacturi ng practices, standards, guidelines and regulations promulgated and published by FDA, EMA or any other applicable Regulatory Authorities having jurisdicti on over the Manufacture, Development or Commercializat ion of any product ( and any precursor steps ), as applicable, relating to the testing, manufacturing, processing, packaging, holding or distribution of drug substances and finished drugs including any standar ds, guidelines and regulations as promulgated by, a s applicable : ( a ) the FDA under and in accordance wit h the U.S. Federal Food, Drug and Cosmetic Act and Title 21, Parts 210 and 211 of the U.S. Code of Federal R egulations, ( b ) the EMA and the EU Commission under European Directive 2003/94 / EC, and/or ( c ) the ICH H armonised Tripartite Good Manufacturing Practice Gu ide For Active Pharmaceutical Ingredients ( ICH Q7 ), as such standards, guidelines and regulations may be a mended from time to time