The Pharmaceutical Journal
Vol 279 No 7473 p394
13 October 2007

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Bring forward electronic submission of licensing applications

Regulatory affairs professionals are upping the pressure on medicines regulators to speed up moves towards the electronic submission of licensing applications.

Speaking at last month’s annual meeting of The Organisation for Professionals in Regulatory Affairs (TOPRA), Lars Olsen, executive vice-president for research and development at Leo Pharma, said that national agencies and European bodies were not sufficiently geared up to accepting submissions in eCTD (electronic Common Technical Document) format.

Leo Pharma, he said, could only submit a recent licensing application in eCTD format in three countries — Belgium, the Netherlands and the UK. This meant that 600,000 pages had to be printed and bound in 1,673 binders for submission to regulatory authorities in 13 other countries.

Mr Olsen accepted that the EU had committed to accepting eCTD submissions by the end of 2009, but said that this would present regulators with a considerable technical and financial challenge.