Mhra Revises Electronic Submission Guidelines

To help companies move to electronic common technical document (eCTD) format, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced it will accept electronic submissions that are compliant with the folder structure and naming conventions of the eCTD standard but that do not have an extensible markup language (XML) backbone.
Since last August all electronic submissions to the MHRA have had to comply with the new eCTD submission requirements. The MHRA said it understands that the requirements have put a burden on industry.
So as an interim measure to facilitate the transition to eCTD, the MHRA will begin to accept electronic submissions that do not have an XML backbone.
The MHRA plans to switch to an all-electronic system by 2009, and, according to the agency’s announcement, the European Union has a similar goal. The Association of the British Pharmaceutical Industry has set targets for meeting eCTD requirements in submissions for new active substances by April 2008 and in all applications by the end of 2008, according to the MHRA.
The MHRA’s eCTD guidelines can be viewed at