In computing, DOC or docx (an abbreviation of ‘document’) is a filename extension for word processing documents, most commonly in the proprietary Microsoft Word Binary File Format.
Electronic Common Technical Document eCTD
The Electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information. The content is based on the Common Technical Document (CTD) format.
It was developed by the International Conference on Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). As of January 1, 2008, the U.S. Food and Drug Administration announced that the eCTD is the preferred format for electronic submissions.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) is a Brussel-based trade association founded in 1978 representing the research-based pharmaceutical industry operating in Europe.
Through its membership of 33 national associations and 40 leading pharmaceutical companies, EFPIA represents 1,900 EU companies committed to researching, developing and manufacturing new medical treatments.
The European Medicines Agency (EMA) is a European Union agency for the evaluation of medicinal products.
European Product Assessment Reports (EPAR)