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EMEA plans e-marketing submissions only

The European Medicines Agency has announced plans to switch to electronic-only marketing submissions for products in the Centralised Procedure, including for post-authorisation activities, as part of a wider EU initiative to support efficient decision-making within the European Regulatory Network.

The European Medicines Agency (EMEA) has announced plans to switch to electronic-only marketing submissions for products in the Centralised Procedure, including for post-authorisation activities, as part of a wider EU initiative to support efficient decision-making within the European Regulatory Network.

The current system will remain in place until July 1 2008, after which time the agency will start accepting e-submissions for all marketing authorisation applications (new and existing) plus all types of submission through the centralised procedure, including renewals, supplementary information and variations. By January 1 2009, the EMEA will "strongly recommend" the sole use of e-submissions, which should (by 1 July 2009) take the form of an Electronic Common Technical Document (eCTD).

By the end of 2009, the eCTD should provide the sole vehicle for all marketing authorisation submissions within the European Union, as agreed by the Heads of Medicines Agencies (HMA) in 2005.

A key benefit of the new digital system is that the eCTD enables an improved filing and recall system for data on medicines. While each part of a submission can be filed and dealt with separately, dedicated viewing tools will enable the agency to improve its management of product lifecycles, helping reviewers to keep track of changes made subsequent to an initial marketing submission.

It also shows relationships between dossiers and displays all current documentation for a product easily and quickly. Overall, the measures are designed to improve efficiency and organisation, as well as reduce administrative costs and burden at the EMEA, of marketing authorisations in the EU.

eCTD and the Centralised Procedure

The use of the eCTD is also designed to harmonise the regulatory process and make it more efficient, which will have a streamlining effect where the Centralised Procedure is employed to provide marketing authorisation in several Member States simultaneously.

All National Competent Authorities (NCAs) must also accept eCTD format marketing submissions by the end of 2009, however e-submissions will not be mandatory in every Member State by this deadline.

The EMEA has also made clear its plans to implement a central repository for use by NCAs in the context of the Centralised Procedure. A Central Repository Implementation Group has been formed, representing the EMEA and 14 Member States. Once fully designed and set up, for products going through the Centralised Procedure an eCTD will be loaded into the central repository for technical validation by the agency. Thereafter, the submission will be registered for access by all Member States. The new system is currently being tested.

A 'Q&A' document explaining the changes can be read via: http://www.emea.europa.eu/pdfs/human/regaffair/59687007en.pdf

5th February 2008

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