EMA: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M2 on electronic common technical document (eCTD) - file format criteria - Step 5

ICH M2 EWG pursued the challenging task of recommending international solutions by identifying the key areas (domains) that demanded M2\'s immediate attention. ICH M2 EWG concluded that the best approach would be to recommend a technological framework consisting of open international standards and interoperable products, or to identify proprietary solutions that are de facto standards, since the products offer all the required functionality