The eCTD in Europe – From the Regulatory Affairs’ Perspective Dr. Dorit Thormeyer Dr. Ebeling & Assoc. GmbH, Hamburg (Germany) In regard of the implementation of the Common Technical Document (CTD), a harmonisation for the registration of pharmaceuticals has been achieved in the three main regions of interest of the pharmaceutical industry, Europe, the United States of America, and Japan, in November 2000. Based thereon, the International Conference on Harmonisation (ICH) – Multi-disciplinary Group 2 (M2) Expert Working Group (EWG) developed the eCTD specification, a standard, that enables pharmaceutical companies with the submission of regulatory information in electronic format to the regulatory authorities.
Although all stakeholders within the European and international network of Drug Regulatory Affairs act on the level floor of the implemented legislation, different interpretations of the guidance documents, different understanding of the provided data or divergent conclusions drawn up may still occur. In December 2008, the EMEA announced plans to mandate the use of eCTD format from 01 January 2010 for electronic-only submissions in the centralised procedure (EMEA/572459/2008). This means for the regulatory affairs’ work not only more responsibility but also to know and to realise the current national and international guidelines and specifications. Based on the most current international requirements, this article will present examples, such as the application of bookmarks, hyperlinks, file formats, and others, which may help to understand the regulatory guidelines better, and which may give advice for a sufficient eSubmission. |
