Summary

Language: English

Since the early 1990ies with the internet is available for the populace. In 1998 XML (Extensible Markup Language) became standard for portable data formats in the internet. In 2003 the ICH M2 EWG has defined the specification for the XML-based eCTD (Electronic Common Technical Document). The eCTD is defined as an interface for data transfer of regulatory information from industry to Competent Authorities. The Agencies in more and more European Member States accept electronic submissions of eCTDs. Since the internet operability of XML-based variations of the eCTD is very good some agencies in the E.U. have developed internet portals for electronic submission of variation data portals for eVariations (electronic Variations). eVariations are so long (January 2008) only accepted by the Competent Authorities in Germany, UK and Ireland.

In Germany since 30 March 2007 all national and MRP-/DCP-related variations can be submitted to the BfArM online via the web portal of PharmNet.Bund, a network system of existing (e.g. AMIS) and new databases/information systems developed in cooperation between German Authorities. In UK in April 2006 the MHRA launched the Sentinel information management program which is in contrast to PharmNet.Bund a complete new development. The main functionality is the ability to receive submissions of dossiers and variations electronically online via a secured external portal. In Ireland the IMB developed the Regulatory Information Online (RIO) Project for online electronic submission of dossiers and variations. The other European Competent Authorities do not offer online Portals for eVariations.

The implementation of databases for storage of electronically submitted dossiers and eVariations differ between the Competent Authorities. Only the Sentinel online portal in UK allows the upload of XML-based eVariations for automated update of respective databases (this is planned for the RIO portal in Ireland). It is clear that eVariations and databases will become central in workflows of processing eCTDs and its life cycle management. The EMEA recently has realized a central repository for the storage of eCTD dossiers. National Competent Authorities have the possibility to connect to the repository. All these features together are very important steps for the implementation of electronic Life Cycle Management (eLCM) of dossiers. With the online Portals and eVariations functionalities at least technically the fundament for eLCM is laid down.

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